This report compiles several important developments that shaped the healthcare and life sciences industries in 2024 and spotlights key areas to watch in 2025. Each section addresses either an industry sector within healthcare...more
The Centers for Medicare and Medicaid Services (CMS) has deferred taking immediate action on its low wage index hospital policy in light of the US Court of Appeals for the DC Circuit’s decision in Bridgeport Hospital v....more
The US Supreme Court’s decision in Loper Bright Enterprises v. Raimondo and Relentless v. Department of Commerce, which overrules the longstanding Chevron doctrine that required federal courts to defer to administrative...more
7/9/2024
/ Administrative Procedure Act ,
Chevron Deference ,
Chevron v NRDC ,
Government Agencies ,
Judicial Authority ,
Life Sciences ,
Loper Bright Enterprises v Raimondo ,
Regulatory Authority ,
Relentless Inc v US Department of Commerce ,
SCOTUS ,
Statutory Interpretation
The US Supreme Court recently debated the future of the legal precedent known as Chevron deference in two separate cases arising out of the National Marine Fisheries Service’s statutory interpretation of the Magnuson-Stevens...more
The Centers for Medicare & Medicaid Services (CMS) proposed on April 23, 2023 two rules that would affect Medicaid managed care: Ensuring Access to Medicaid Services (CMS 2442-P) and Medicaid and Children’s Health Insurance...more
The Biden administration announced on January 30, 2023 that the COVID-19 Public Health Emergency (PHE) would officially end on May 11, 2023. The PHE declaration, which first was issued by the Secretary of the US Department of...more
The impending end of the COVID-19 national and public health emergency will present a complicated landscape to navigate for hospital systems, which look to minimize the impact of the transition to post-pandemic normality....more
Pressure continues to mount on the US Department of Health and Human Services (HHS) to reconsider and revise its August 2022 final rule modifying the No Surprises Act independent dispute resolution (IDR) process. The rule is...more
12/9/2022
/ Billing ,
Department of Health and Human Services (HHS) ,
Dispute Resolution ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
No Surprises Act (NSA) ,
Out of Network Provider ,
Rebuttable Presumptions ,
Surprise Medical Bills
Following the US Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, the federal government has issued various guidance to healthcare providers reinforcing federal legal protections or requirements...more
A federal judge in Texas held on February 23 that the federal government’s interim final rule implementing the independent dispute resolution (IDR) process established by the No Surprises Act conflicted with the plain...more
The US Department of Health and Human Services (HHS) recently announced that it will make $25.5 billion available in new COVID-19 relief funds to providers through the Health Resources and Services Administration (HRSA). To...more
In the complex world of Medicare reimbursement, there are a multitude of payment formulae, mathematical adjustments, and reimbursement calculations that translate congressional policy into operational payments for hospital...more
January 28 was designated as “health day” for President Joe Biden’s early push of executive orders, with two new executive actions added to a growing list. The Executive Order on Strengthening Medicaid and the Affordable Care...more
The US Court of Appeals for the Fifth Circuit issued its ruling in the landmark HIPAA case between The University of Texas MD Anderson Cancer Center (MD Anderson) and the US Department of Health and Human Services (HHS). The...more
The US Department of Health and Human Services (HHS) issued two welcome announcements on October 22 relating to the CARES Act Relief Fund Provider Relief Fund (PRF). First, the agency expanded the pool of eligible recipients...more
The Centers for Medicare and Medicaid Services (CMS) recently announced that it intends to resume both prepayment and postpayment medical reviews conducted by the Medicare Administrative Contractors, Supplemental Medical...more
Companies marketing products or services for coronavirus (COVID-19) should be aware of key areas of healthcare law and regulation, including Food and Drug Administration regulation, clinical laboratory testing oversight,...more
7/9/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratory Testing ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Immunity ,
Product Defects ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Risk Mitigation ,
Suppliers ,
Supply Chain ,
Telehealth
In an informative decision for challenging rules that portend government overreach, the US Court of Appeals for the District of Columbia Circuit upholds the invalidation of the Centers for Medicare and Medicare Services’ drug...more
With just days left until provider attestations are due related to acceptance of CARES Act Provider Relief Funds, the US Department of Health and Human Services (HHS) recently updated its FAQs providing some additional...more
The Centers for Medicare & Medicaid Services released a second, sweeping interim final rule in response to the coronavirus (COVID-19) pandemic on April 30, 2020. Building on the agency’s unprecedented March 31, 2020...more
The Centers for Medicare & Medicaid Services (CMS) announced on April 26 that it will no longer be accepting new applications for the Medicare Accelerated/Advanced Payment Program (AAPP)....more
Medicare (and in the future Medicaid) providers that receive grant money under the CARES Act Relief Fund must pay close attention to the terms and conditions of the assistance and rigorously document how the funds are used to...more
Not to be confused with the $100 billion in Provider Relief Funds established as grants to healthcare providers through the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), Congress also broadened the access to...more
On March 30, 2020, the Centers for Medicare & Medicaid Services released a stunning and far-reaching interim final rule to address the coronavirus (COVID-19) crisis. The rule is a comprehensive set of policy changes designed...more
In the face of the coronavirus (COVID-19) pandemic, the US president’s National Emergency Declaration, issued on March 13, set in motion several actions required of other agencies to provide the regulatory relief needed to...more
3/20/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Emergency Management Plans ,
EMTALA ,
Health Care Providers ,
Healthcare Facilities ,
Healthcare Workers ,
Medicaid ,
Medicare ,
Stark Law ,
Trump Administration ,
Waivers