HHS ushers in a new enforcement regime

• The reorganization creates a new assistant secretary position to oversee enforcement of rules and regulations, and already it's stoking fears among patient advocates and health care lawyers that rulemaking and enforcement will become politicized.

State of play: The existing HHS Office of Medicare Hearings and Appeals, Office of Civil Rights, and Departmental Appeals Board will all report to a new assistant secretary of enforcement.

• The change will streamline and bolster efforts to combat fraud, waste and abuse, per HHS.
• The agency did not respond to questions about the specific rationale for the change.

What they're saying: Combining the functions of these offices "is going to bring together parts of HHS with similar skills sets — enforcement, adjudication, and dispute resolution," David Mansdoerfer, who worked as a senior HHS official in the first Trump administration, told Axios.

• "This should allow for greater efficiency and management as resources within this office will be able to be better deployed by a single leader," he said.

The other side: Patient advocates are concerned that the consolidation will make HHS enforcement of patient privacy rules and violations of consumer rights less effective.

• "The plan appears to strip [the Office of Civil Rights] of its direct reporting line to the HHS Secretary, which could diminish its ability to enforce civil rights and HIPAA protections," the National Health Law Program said in a statement about the reorganization.
• Some onlookers are also dubious that the change will make HHS more adept at rooting out fraud, waste and abuse.
• "When they talk about focusing on waste, fraud and abuse, the Medicare appeals process isn't really where that stuff is dealt with," David Lipschutz, co-director of the Center for Medicare Advocacy, told Axios.

Between the lines: Adding a new head of enforcement could also make enforcement actions more politically motivated, advocates worry.

• "There is certainly a concern that if they are under the thumb of HHS ... there will be more of a focus on the policy preferences of a given administration, rather than focus on existing Medicare rules and statutes," said Lipschutz, a health care lawyer.
• For instance, the administration is sometimes a party to cases brought in front of the Medicare appeals office.

• "You don't want a situation where, you know, the presumption is that [the Centers for Medicare and Medicaid Services] is always right. You want a degree of independence from them," he said.

Zoom in: The Departmental Appeals Board reviews and resolves disputes between HHS and outside groups including states, nursing homes, Medicare beneficiaries and universities.

• The Office of Medicare Hearings and Appeals adjudicates disputed claims for Medicare coverage raised by beneficiaries.
• The Office of Civil Rights takes enforcement actions against health providers and other entities that discriminate against patients or violate health data privacy laws. During the first Trump administration, it also enforced conscience rules that allowed providers to opt out of services due to personal beliefs.

Of note: HHS communications so far indicate that the new assistant secretary of enforcement will not be responsible for the Office of Inspector General, which oversees agency actions to make sure they're appropriate and efficient.

• President Trump recently nominated Republican attorney Thomas March Bell to be HHS inspector general.
• The inspector role has historically been thought of as nonpartisan, but Trump fired several inspectors general — including at HHS — when he took office. The former HHS inspector general Christi Grimm has gone to court to challenge her firing.