ARTICLE
23 November 2016

Out With The Old Rules? Will Trump And Republicans Target Health Care Regulations For Reversal In The New Year Under Congressional Review Act?

The Congressional Review Act (CRA) has been used to overturn only one final rule in 20 years, but that situation may be about to change.
United States Food, Drugs, Healthcare, Life Sciences

The Congressional Review Act (CRA) has been used to overturn only one final rule in 20 years, but that situation may be about to change.  According to a new Congressional Research Service (CRS) analysis, a "specific set of circumstances" will occur when President-elect Trump is sworn in, namely, turnover in White House party control when the incoming President shares a party affiliation with a majority in both houses of Congress.  This highly-unique development means that conditions are right for successful use of the CRA authority to block certain Obama Administration rules in 2017.

By way of background, the CRA enables Congress to rescind a final rule within a specified period of time using expedited procedures.  Typically presidents can be expected to veto resolutions overturning their own regulations, as President Obama has on five occasions.  However, a party change provides a new opportunity to revisit controversial regulations, as when President George W. Bush signed into law a CRA resolution overturning a controversial Clinton Administration Occupational Safety and Health Administration ergonomics rule in 2001.

In a November 17, 2016 memo to Congress, CRS lists major rules issued by the Obama Administration that are potentially subject to consideration under the CRA procedures in the 115th Congress, which begins January 3, 2017.  CRS estimates that final rules submitted to Congress after May 30, 2016 will be subject to such review (although the specific timeline is subject to change). Department of Health and Human Services (HHS) rules that are potentially eligible for disapproval under the CRA as of November 16, 2016, include the following:

  • ONC Health IT Certification Program: Enhanced Oversight and Accountability (Oct. 19, 2016)
  • Medicare And Medicaid Programs; Reform Of Requirements For Long-Term Care Facilities (Oct. 4, 2016)
  • Emergency Preparedness Requirements For Medicare And Medicaid Participating Providers And Suppliers (Sept. 16, 2016)
  • Medication Assisted Treatment For Opioid Use Disorders (July 8, 2016)
  • Medicare Program; Medicare Clinical Diagnostic Laboratory Tests Payment System (June 23, 2016)
  • Medicare Program; Medicare Shared Savings Program; Accountable Care Organizations–Revised Benchmark Rebasing Methodology, Facilitating Transition To Performance-Based Risk, And Administrative Finality Of Financial Calculations (June 10, 2016)
  • Annual 2017 Medicare payment update regulations for inpatient hospital services, long-term care hospitals, skilled nursing facilities, inpatient rehabilitation facilities, hospices, and inpatient psychiatric facilities.

A number of other very recent HHS rules are not listed, including sweeping reforms to the Medicare physician fee schedule update framework and various updates to calendar year 2017 Medicare payment policies. Presumably these rules had not been formally submitted to Congress prior to the CRS analysis but would also be subject to the CRA process.  There are a number of other HHS final rules now undergoing regulatory clearance at the Office of Management and Budget, including final revisions to civil monetary penalty (CMP) rules, safe harbors under the Anti-Kickback Statute, changes to the provider enrollment process, Office of Inspector General's exclusion authorities, and 340B program CMPs and ceiling price regulations.  Should these final rules be published before the end of the year, they also likely would be subject to review.

Of course, just because a rule is eligible for review does not mean it will be challenged by Congress, but it does present stakeholders with an opportunity to revisit regulations issued during the closing months of the Obama Administration.

Finally, more attention can be expected regarding the fate of existing regulations in the new Administration.  In a new video, President-elect Trump announced:  "I will formulate a rule which says that for every one regulation, two old regulations must be eliminated.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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