Public Health Law Map - Beta 5 - Medical and Public Health Law Site

Given the complex regulations in medical care, and the Draconian consequences of
noncompliance, this process is very important for medical care practitioners. In
addition to the IRS, the DOJ will give advisory opinions on potential antitrust
problems, and the HCFA OIG now provides advisory opinions on potential fraud
and abuse issues and other HCFA regulatory matters. These are not binding in the
way that IRS letter rulings are, but they are very strong evidence of the views of
the agency. It would be surprising if the agency were to take enforcement action
against an entity that had a clean bill of health in an advisory ruling.
The most important consideration in requesting agency advice is the timing: you
should do it before you enter into the transaction. The agencies make it clear that
this is not a mechanism for immunizing past violations. They are free to investigate
any existing transaction they learn about through the request for an advisory ruling.
Since the request for advice does show good faith in trying to determine how to
comply with the law, it is probably better to request an opinion on a questionable
practice than to continue it and hope it is not discovered. These opinions should
never be requested without the assistance of counsel who can ensure that the issues
are properly framed so the agency will address all of them. If an issue is not
directly addressed by the advisory opinion, the requester cannot rely on the opinion
in planning the transaction.
3. Enforcement
A key value of administrative agencies is that they have many more enforcement
tools than do private litigants or law enforcement agencies. In addition, if provided
for in their enabling legislation, an agency can refer a matter to the DOJ or to state
and local prosecutors for criminal prosecution. In medical care, regulatory agencies
are especially powerful because they control access to payment and to the licenses
that allow medical care practitioners and facilities to provide medical services.
a) Permits, Licenses, and Registrations
As a regulated industry, medical care practitioners and facilities are dependent on
licenses, permits, and registrations controlled by the regulatory agencies. With
limited exceptions under the Constitution for religious healers, no one can provide
medical care services without a license from the state. Physicians also need a
registration with the Drug Enforcement Administration to prescribe certain
controlled substances. Hospitals will generally have a license from the state to
operate as a hospital, as well a local fire- safety permit as a commercial building,
and a food- handling permit to operate a cafeteria and to provide food to the
patients. In many jurisdictions, private clinics must be licensed as health care
facilities, and all of them must meet the standards for commercial buildings open to
the public.
Permits, licenses, and registrations are not legal rights or entitlements. They are
privileges awarded by the state to persons or entities who meet the applicable
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