Robert E. Wanerman, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Law360, in “Health Regulators Likely to Tread Carefully Post-Chevron,” by Theresa Schliep. (Read the full version – subscription required.)
Following is an excerpt:
The demise of Chevron deference at the U.S. Supreme Court on Friday will likely encourage or fortify challenges to agency rulemaking on matters of health policy in the U.S., from Medicare reimbursement decisions to FDA rules on laboratory-developed tests.
The decision, representing a historic shift in power from regulators to the courts, also risks making the agencies that oversee health and medicine more cautious, potentially slowing action during public health emergencies and chilling dialogue between agencies and industry players, experts warned. …
While opinions vary on precisely how seismic the ruling will prove to be, the decision will likely especially impact the work of the U.S. Food and Drug Administration, U.S. Department of Health and Human Services, and Centers for Medicare & Medicaid Services, which issue reams of guidance every year and oversee highly technical and scientific areas of the law.
"For entities that are regulated — hospitals, physicians, laboratories, etc. — it now means that it's going to be much, much easier to challenge an agency regulation," Robert E. Wanerman, an Epstein Becker Green member and expert on healthcare and administrative law, told Law360.
Yet some experts cautioned this power shift may make agencies behave prophylactically and move more slowly, taking time to issue guidance that they can defend in court. It thus may take longer to respond to public health emergencies, when speed is of the essence, Wanerman added.
"If there's another pandemic, it will be difficult for HHS writ large to respond," he said. "It will be harder for agencies to publish regulations since they are going to have to parse statutory language in much more detail than they did in the past."
