Trump’s regulatory freeze delays HHS rules

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A regulatory freeze issued by the White House has delayed HHS poverty guideline updates used to determine eligibility.

An announcement from the White House freezing all new and pending federal regulations has forced the Department of Health and Human Services to withdraw a dozen rules, including one in which the freeze could delay eligibility for those with exchange plans, Medicare Part D or Medicaid.

HHS poverty guidelines, which are updated annually, are used to determine eligibility for government health programs such as Medicaid, Medicare Part D, Children’s Health Insurance Program (CHIP) and ACA tax credits. This year’s guidelines, which were scheduled to take effect on Jan. 19, reflected a 1.3% increase between calendar years 2015 and 2016.

However, the guidelines have been delayed due to a regulatory freeze issued by White House last week. The memo, sent from President Trump's chief of staff Reince Priebus to the heads of all government agencies, requires any regulations submitted to the Office of the Federal Register (OFR) to be temporarily postponed “in order to ensure the President’s appointees or designees have the opportunity to review any new or pending regulations.” 

The memo allows exemptions "for emergency situations or other urgent circumstances relating to health, safety, financial or national security matters." Regulations that have been published on the federal register but have not yet take effect, will be postponed 60 days from January 20. 

Currently, the HHS 2016 poverty guidelines remain in effect. But in a letter to OFR Director Oliver Potts dated January 18, HHS Deputy Director Vanessa Jones made a specific request for the poverty guidelines to be published immediately.

“Multiple programs in [the Centers for Medicare & Medicaid Services] rely on the 2017 guidelines for eligibility determinations at the start of the year,” she wrote. “A delay in the issuance of the guidelines will cause an increased wait period for program-eligible potential recipients of Medicaid, CHIP, Medicare Part D coverage and Marketplace tax credits/cost sharing reductions.”

When asked for comment, HHS directed FierceHealthcare to the agency's FAQs on poverty guidelines. 

Additionally, HHS has withdrawn a notice from the Assistant Secretary for Preparedness and Response (ASPR) issuing declarations under the Public Readiness and Emergency Preparedness (PREP) Act to continue development of a Zika virus vaccine and provide liability immunity to manufacturers. An annual adjustment to civil monetary penalties was also withdrawn. 

The regulatory freeze has also delayed several rules born out of the 21st Century Cures Act.

The first, scheduled to publish on Jan. 24, delegated authority to Office of the National Coordinator for Health IT (ONC) to certify health IT developers and oversee the EHR reporting program and the HIT advisory committee.

Another, also scheduled to publish Jan. 24, initiated the process of renewing the contract for the ONC’s Approved Accreditor, which oversees the government's EHR certification program.

The American National Standards Institute (ANSI) is the ONC's current Approved Accreditor. It's a three-year term that expires in June 2017.

A notice from the National Institutes of Health (NIH) was also withdrawn—it would have delegated authority to the agency to establish a task force authorized under 21st Century Cures Act to "refine the clinical trials data registry."

A spokesperson for the ONC directed questions regarding the rule withdrawals to the White House press office.