The regulations looked innocuous enough last December when they were published in the Federal Register under the title "Medicare and Medicaid Programs; Hospital Conditions of Participation."
But they had the same effect as a seismic tremor on the ocean floor.
A tidal wave of public comments has washed into HCFA's Baltimore headquarters. The agency has received between 55,000 and 65,000 written comments on the proposed regulations. And that's just a guess. They haven't been counted.
This is HCFA's first total overhaul of the Medicare conditions of participation since 1986. The regulations embrace a new philosophy of quality improvement, which was largely borrowed from the Joint Commission on Accreditation of Healthcare Organizations. They downplay traditional standard-based requirements in favor of a more flexible accountability for results.
"There are lots of issues in these regs. We asked for comments, and we got them," said Rachael Weinstein of HCFA's office of clinical standards and quality. Two weeks after the April 20 due date, there are still 5,000 envelopes waiting to be opened, she said.
HCFA has hired a contractor just to log and track the comments.
"This is very unusual," said Tim Miller, who supervises the public access to comments in HHS' Washington headquarters. "Every now and then we get a blockbuster like this, a 100-year flood. The last thing I remember this big was changing the physician regs. We got 95,000 comments, and on CLIA (the Clinical Laboratory Improvement Act) we got about 65,000. That's the most I can remember in 14 years here."
Just to put it in perspective, as of April 30 the Agriculture Department received an estimated 150,000 cards and letters about proposed regulations that redefine organic foods. Aside from vegetarians, farmers and food-protection lobbies, the affected population could include everyone who eats.
But there are only about 6,000 hospitals in the U.S. Did 10 people from every hospital write in? No one knows yet.
Actually, the new regulations include several peripheral issues that generated volumes of mail in their own right.
For instance, a regulation allows certified registered nurse anesthetists to practice without a doctor's supervision. There are three large boxes sitting in Miller's office in the Hubert H. Humphrey Building that appear to contain letters from nearly every anesthesiologist and nurse anesthetist in the country, plus their patients, arguing one way or the other on that issue.
Also, new regulations on organ transplants generated many letters. That change is being separated from the hospital conditions of participation and will henceforth follow a separate track, Miller said.