CMS Ends Waiver for Nurse Aides, CRNA Expansion, and Drugs from Canada Banner Image

Health Care Law Blog

CMS Ends Waiver for Nurse Aides, CRNA Expansion, and Drugs from Canada

June 21, 2022

For more information about this blog post, please contact Khaled J. KleleRyan M. MageeBrianna J. Santolli, Connor Breza, or Labinot Alexander Berlajolli.

CRNAs Allowed to Practice Without Physician Supervision in Michigan, Arkansas, and Alabama

Michigan (HB 4359), Arkansas (HB 1198), and Alabama (HB 268) are the latest states to grant certified registered nurse anesthetists (“CRNAs”) full practice authority without physician supervision.  Each state has effectively opted out from federal regulations that require physician supervision of CRNAs.  According to the American Association of Nurse Anesthesiology, the governors of more than 20 states and Guam have exercised such exemptions.

FDA Releases Compliance Guide for Drug Importation from Canada

On May 25, 2022, the Food and Drug Administration (“FDA”) released a compliance guide regarding the Importation of Prescription Drugs final rule (85 FR 62094).  The final rule aims to reduce costs by allowing the importation of certain prescription drugs from Canada.  Among other things, the new guidance explains that importation pursuant to Section 804 of the Federal Food, Drug, and Cosmetics Act will be implemented through Section 804 Importation Programs (“SIPs”), whereby an Importer, which may be a pharmacist or a wholesaler, will import eligible prescription drugs.  To be eligible for importation, a drug must be approved by Canada’s Health Products and Food Branch (“HPFB”), and it must have HPFB‑approved labeling when marketed in Canada.  Certain drugs, like controlled substances, are excluded from eligibility.

HHS Withdraws Trump Administration SUNSET Rule

On May 27, 2022, the Department of Health and Human Services (“HHS”) issued a final rule (87 FR 32246) withdrawing the Securing Updated and Necessary Statutory Evaluations Timely (“SUNSET”) rule.  The SUNSET rule would have required HHS to do a massive review of its existing regulations within five years of the SUNSET rule’s effective date.  Any rule that was not reviewed within five years would have been removed entirely.

CMS Temporary Nurse Aide Waiver for Nursing Home Ends

On June 6, 2022, a Centers for Medicare and Medicaid Services (“CMS”) waiver, which allowed nursing homes flexibility to hire temporary nurse aides for more than four months without the necessary training and certification requirements, expired.  CMS stated that ending the waiver, which was adopted in response to the COVID‑19 pandemic, is key to improving quality of care.  Now, nursing homes have until October 7, 2022 to train and certify temporary nurse aides as nursing assistants.  More information regarding the expiration of the waiver is available here.

Our Team

Khaled John Klele

Khaled John Klele
Partner

​Ryan M. Magee

​Ryan M. Magee
Partner

Labinot Alexander Berlajolli

Labinot Alexander Berlajolli
Associate

Connor Bradford Breza

Connor Bradford Breza
Associate

Brianna J. Santolli

Brianna J. Santolli
Associate

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