HHS and HCFA are preparing to rush into the vacuum created by congressional inaction and the interim between the election and the inauguration of a new president to unleash some final rules on controversial healthcare issues.
Most of these regulations--ranging from medical records privacy to Medicare fraud and abuse--have been in the works for months or even years. Officials know that if that president is George W. Bush, it would be the last chance to implement many of them as conceived by the Clinton team.
"A number of rules and regulations have been held hostage to political pressures," says Lawrence Goldberg, director of national healthcare affairs at Deloitte & Touche's Washington office. "The intervening months between the election and the new Congress allows the president to issue the regulations that he wants to issue without those political pressures."
The most anticipated of the regulations are those pertaining to medical privacy. The Health Insurance Portability and Accountability Act of 1996 called for HHS to issue regulations if Congress could not pass privacy legislation within three years.
"The problem is, these regulations are not national law. They're just agency regulations," says Harry Rhodes, director of health information management products and services at the Chicago-based American Health Information Management Association. "There are still a lot of loopholes and a lot of questions that need to be worked out" that weren't addressed in the proposed regulations issued a year ago.
Regardless of what the final regulations say, consumers and the healthcare industry will likely continue to butt heads over side issues such as whether patients have the right to sue if their privacy has been violated.
"People still are not going to be pleased," Rhodes says.
Observers have said they expect HHS to issue the privacy regulations before the end of the year.
Another set of regulations slated to come out soon are those implementing the so-called "Stark II" law, named after its sponsor, Rep. Fortney "Pete" Stark (D-Calif.). The 1992 law prohibits physicians from referring patients to healthcare facilities in which they own an interest, with some exceptions. HHS' inspector general's office issued proposed regulations in January 1998. The hospital lobby is concerned mainly with three potential final rules:
* HCFA may complete a proposed Medicaid regulation to close the "intergovernmental transfer" loophole that allows states to artificially inflate the federal government's contribution to their Medicaid expenditures.
The loophole has been called a scam by outgoing Senate Finance Committee Chairman William Roth (R-Del.). But the American Hospital Association and other hospital groups oppose closing that loophole, claiming that the extra dollars fund care for the uninsured.
* HCFA has said that it will issue in January a final "provider-based" rule, which would determine which hospital-owned off-site facilities are eligible for payment under the Medicare outpatient prospective payment system. Hospitals want all of their outpatient facilities to qualify as provider-based organizations, which receive higher payments under the PPS than independent facilities.
* By the end of the year, HCFA is expected to issue new Medicare conditions of participation that will require all hospitals that accept Medicare payments to have ongoing medical-error reduction programs, including mechanisms for reducing medication mistakes. The Quality Interagency Coordination Task Force called for those new conditions in a report it sent to President Clinton earlier this year (Feb. 28, p. 2).
Congress, which has not yet adjourned for the year, could pass legislation on any of these soon-to-be-released regulations if lawmakers are unhappy with the new rules.
As just one example of an area of potential action, Congress is considering Medicare legislation, which in addition to adding $32.6 billion to Medicare payments for providers and health plans, would include provisions on intergovernmental transfers and provider-based status under the outpatient PPS.
"Had Congress adjourned for the year, there might be more regulations issued," says Herb Kuhn, vice president of advocacy at Premier, an alliance of not-for-profit hospitals.