Judith Waltz

Judith Waltz

Foley & Lardner LLP

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Medicare Coverage: CMS Finalizes New Pathway for Breakthrough Devices

The Centers for Medicare & Medicaid Services (CMS) released a Final Notice for Transitional Coverage for Emerging Technologies (TCET), effective August 12, 2024, to provide “transparent, predictable, and expedited national...more

10/15/2024  /  Centers for Medicare & Medicaid Services (CMS) , Food and Drug Administration (FDA) , Medical Devices , Notice Requirements , Reimbursements

What Does the End of Chevron Deference Mean for Federal Health Care Programs?

On June 28, 2024, the Supreme Court rejected the doctrine of Chevron deference in the closely watched case of Loper Bright Enterprises v. Raimondo. In a 6-3 decision, the Court held that Chevron’s rule that courts must defer...more

7/2/2024  /  Administrative Procedure Act , Centers for Medicare & Medicaid Services (CMS) , Chevron Deference , Department of Health and Human Services (HHS) , Federal Health Care Programs (FHCP) , Food and Drug Administration (FDA) , Government Agencies , HRSA , Loper Bright Enterprises v Raimondo , Magnuson-Stevens Act (MSA) , Medicaid , Medicare , National Marine Fisheries Service , SCOTUS

COVID-19 At-Home Tests: Do CLIA Requirements Apply and what do Health Care Providers Need to Know?

Demand for COVID-19 tests, including over-the-counter at-home tests, has soared with the surge of the Omicron variant of the COVID-19 virus. However, health care providers, employers, and individuals have lacked clarity on if...more

1/5/2022  /  Centers for Medicare & Medicaid Services (CMS) , CLIA , Coronavirus/COVID-19 , Food and Drug Administration (FDA) , Health Care Providers , New Guidance

COVID-19: Ten Things to Know about Laboratory Testing

Laboratory testing is a key factor in identifying or diagnosing COVID-19 patients, including during the asymptomatic phase, and determining appropriate treatment. With respect to COVID-19, laboratory testing is also critical...more

7/29/2020  /  Centers for Disease Control and Prevention (CDC) , Centers for Medicare & Medicaid Services (CMS) , CLIA , Clinical Laboratory Testing , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Infectious Diseases , Public Health , Virus Testing

The Battle Over Drug Pricing: First Shot Targets Pharmacy Benefit Managers

On July 18, 2018, the federal Department of Health and Human Services (HHS) sent a proposed rule to the Office of Management and Budget (OMB) for review and clearance. While the substance of the proposed rule is not yet...more

8/8/2018  /  Anti-Kickback Statute , Department of Health and Human Services (HHS) , Drug Pricing , Food and Drug Administration (FDA) , OMB , Out-of-Pocket Expenses , Pharmacy Benefit Manager (PBM) , Prescription Drugs , Proposed Rules , Request For Information , Safe Harbors

New FDA Commissioner Hits the Ground Running

Fresh off his noticeably smooth confirmation, the new Commissioner of Food and Drugs, Dr. Scott Gottlieb, appeared before Congress last Thursday and unveiled his strategic initiatives and priorities for the Trump Food and...more

6/1/2017  /  Biosimilars , Drug & Alcohol Abuse , Drug Pricing , FDA Approval , FDA Commissioner , Food and Drug Administration (FDA) , Generic Drugs , Opioid , Trump Administration
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