HHS vows to lighten up on regs
Promises of regulatory savings met with skepticism
Federal officials say they can save hospitals $600 million a year in administrative costs by eliminating obsolete and burdensome regulations for participation in Medicare, but the announcement was greeted with caution and skepticism.
The proposal to revamp Medicare’s conditions of participation, or COP, came with the largest single dollar-savings in a bulletpointed, 44-page report released by HHS last week outlining areas where regulators in the massive federal agency say they can eliminate rules without harming patient care.
Overall, the plan touched on dozens of possible changes in regulations for hospitals, payers, devicemakers, states and Medicare beneficiaries. Regulators pledged to make devices easier to bring to market, privacy practices easier to communicate to patients, and scientific research involving human subjects more streamlined, among other topics.
The report came in response to a Jan. 18 executive order from President Barack Obama that mandated all federal agencies submit a plan to review significant regulations with an eye toward listening to public comment, imposing the least-burdensome rules, and reducing redundancy and overlap for industries governed by multiple agencies.
While the document was short on specific details, some observers cheered the overarching goals.
“We share the broad goal of the administration to improve burdensome or inefficient regulations,” Lisa Grabert, senior associate director of policy at the American Hospital Association, said in an e-mailed statement. “As more guidance and specifics are provided by HHS, we will review them carefully to ensure that, as intended, regulations are streamlined and improved.”
The plan says HHS intends to issue the $600 million conditions-of-participation proposal in September as part of an ongoing review.
But as part of that review HHS officials have also made it clear they intend to improve hospitals’ performance on quality measures, including reductions in readmissions and preventable infections, said Marilyn Yager, a former congresswoman and White House healthcare adviser under President Bill Clinton.
“I think my clients are worried that they will be getting rid of some old obsolete COP requirements but then adding new ones,” said Yager, who today works as a senior policy adviser to Washington-based law firm Alston & Bird. HHS “may have a long list of rules they have streamlined or gotten rid of, but in the full volume of what they’ve done, has the burden decreased?”
For example, one way to reduce readmissions would be to mandate as a condition of participation that hospitals make follow-up phone calls to discharged patients. While that would likely reduce readmissions, Yager said, it would also place an additional burden on hospitals.
“If you’re reducing readmissions through revamping COP, you’re probably not doing it with less requirements. Otherwise, why would you be using COP?” Yeager said.
Kenneth Marcus, a partner in healthcare law at Detroit-based law firm Honigman Miller Schwartz and Cohn, said HHS may want to use caution when eliminating any of the conditions that exist today.
He noted that the existing conditions of
participation require hospitals to “provide a sanitary environment to avoid sources and transmission of infections and communicable diseases,” yet thousands of patients contract hospital-acquired infections at hospitals that meet the current standards.
“While the elimination of ‘burdensome’ regulations may play well in Peoria, as the expression goes, sight should not be lost that absent appropriate conditions of participation, the public is exposed to increased risk,” Marcus said in an e-mail.
In addition to potentially sweeping changes in conditions-of-participation rules, the HHS report included a vague reference that “approximately 80” other reforms were being considered to improve access to care.
While taking note of several recent changes already unveiled, the report did not specifically outline any of the new accessimprovement proposals, saying only that “the cumulative effect of removing barriers to efficient and effective patient care will be substantial.”
Of the two dozen other ways HHS would eliminate burdensome rules, one of the most significant for nonhospital healthcare firms is a proposal to ease the privacy burdens on health plans by changing the requirements for how they inform patients of privacy-protection policies.
The rule change is expected to save the insurers $120 million and 2 million “burden hours,” the HHS report says.
HHS noted that the Food and Drug Administration is proposing ways to ease burdens on devicemakers by switching to a paperless adverse-events reporting system and establishing a voluntary device-approval process that could speed up Medicare national coverage determinations.
And HHS is teaming with the White House Office of Science and Technology Policy for a major revision of the rules protecting human subjects of research, potentially eliminating unneeded institutional review board evaluations and improving the speed of information collection. HHS published a notice proposed rulemaking on that point on July 26. <<