The fat lady was onstage, but before she could sing, someone decided to write her a new song.
When HHS decided late last month to delay implementation of controversial patient-privacy regulations and accept a new round of public comments, it resuscitated industry interest groups that thought the expired timetable had flat-lined their lobbying efforts. Mandated by the Health Insurance Portability and Accountability Act of 1996, the privacy regulations were made final in the last days of the Clinton administration.
A second public comment period, which follows the 52,000 comments HHS already fielded from November 1999 to February 2000, may give the healthcare industry a chance to scale back what many view as an excessive solution to the problem of protecting patient privacy.
When the Clinton administration left office, it gave incoming HHS Secretary Tommy Thompson a chance to postpone-and possibly revise-the regulations by neglecting to submit them to Congress for a 60-day review before publishing them in the Federal Register, according to HHS. The agency took advantage of that oversight and delayed the effective date of the regulations to April 14 from Feb. 26.
Once the regulations take effect, most hospitals and health plans will have two years to ensure that their facilities are compliant. That involves restricting the amount of information physicians can share with other caregivers, requiring patient consent for the release of personal health information, and allowing patients to see and request changes to their medical records, among other requirements.
Industry groups, from the American Hospital Association to the American Association of Health Plans, have lobbied aggressively for a rollback of the regulations, citing concerns that they will be prohibitively expensive to implement and disruptive to clinical operations.
Now those concerns will be heard again. Last week, HHS opened a new 30-day public comment period that will end March 30. But the extent to which voicing objections will change the scope and toughness of the regulations is largely unclear.
"The department will review the comments it receives to determine whether changes in the final rule are needed," Thompson said in a written statement. Speaking at the second annual HIPAA summit in Washington last week, Thompson steered clear of specifics regarding the federal privacy regulations, but he did say, "We don't want to make the regulations so burdensome that your husband or wife can't go to the pharmacy to pick up your medication."
HIPAA contains a provision allowing regulators to change the privacy regulations as necessitated by unforeseen circumstances and the test of time. But the regulations may require even more fundamental changes, a situation that could postpone the compliance deadlines even longer, according to HHS.
Regardless of the effect they might have on the final outcome, the groups that represent hospitals and health plans are mobilizing for the new round of pubic comments.
"We plan to work really hard on our comments," said Melinda Hatton, Washington counsel for the AHA. Revising some of the most controversial components of the regulation, Hatton said, will help "meet the twin goals of being able to protect patients' privacy but also allow hospitals to function and provide high-quality care."
The AHA has company in the American Medical Association, which also "welcomes the 30-day comment period announced by the Bush administration as a needed pause in the process to get the rule right and then move forward to begin the serious business of protecting patient privacy," said AMA Trustee Donald Palmisano, M.D., in a written statement.
At least one association representing healthcare organizations, however, is not so keen on overhauling the privacy regulations, which took more than four years to write, review and release.
"We are of the opinion that (Thompson) should go ahead and continue to promulgate these regulations on the original timeline," said Carla Smith, chief executive officer of the Center for Healthcare Information Management in Ann Arbor, Mich.
Even so, Smith said, her organization is asking members to provide advice on any changes they would like to see reflected in the final regulations.
The privacy regulations "differed from the guiding principle that was outlined in the proposed (regulations) in significant ways that may reduce, not improve, consumers' access to quality healthcare," said Karen Ignagni, president and CEO of the Washington-based American Association of Health Plans, in a written statement. The AAHP, she said, will "work with the administration, members of Congress from both sides of the aisle, and others in the effort to craft a balanced standard for medical privacy."