On February 8, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a quality standard memorandum (Memorandum) clarifying that hospitals and critical access hospitals (CAHs) may transmit patient information and orders via text message under certain conditions. Although Computerized
Trends in Transformation
Trends in Transformation, published by Crowell & Moring LLP, focuses on legal and regulatory developments affecting the healthcare sector. The blog covers topics such as Medicare and Medicaid payment systems, hospital and long-term care facility reimbursement policies, healthcare innovation strategies, public health emergency responses, and federal and state government roles in healthcare delivery. It also addresses issues related to healthcare quality reporting, digital modernization in healthcare, nutrition and public health policy, and the impact of natural disasters on healthcare systems. The blog provides updates on legislative and administrative actions influencing healthcare providers, payers, and policy stakeholders.
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An Overview of the States Advancing All-Payer Health Equity Approaches and Development (AHEAD) Model
In September 2023, the Centers for Medicare & Medicaid Services (CMS) released a new state total cost of care (TCOC) model called the States Advancing All-Payer Health Equity Approaches and Development (AHEAD) Model. This model follows in the footsteps of…
Healthcare Policy Developments to Watch in 2024
The ever-changing healthcare policy landscape will witness at the federal level regulatory changes driven by the need to transform healthcare delivery, quality and innovation. Looking forward in 2024, this summary examines a number of healthcare innovation topics that have seen…
Healthcare Policy Developments to Watch in 2024
The ever-changing healthcare policy landscape will witness at the federal level regulatory changes driven by the need to transform healthcare delivery, quality and innovation. Looking forward in 2024, this summary examines a number of healthcare innovation topics that have seen…
CMS Innovation Center Announces Sickle Cell Disease Focus under Cell and Gene Therapy Access Model
On January 30, the Centers for Medicare & Medicaid Services’ (CMS’) Innovation Center announced that sickle cell disease (SCD) will be the first focus of the Cell and Gene Therapy (CGT) Access Model, a model for eligible states and pharmaceutical manufacturers…
CMS Innovation Center Announces Sickle Cell Disease Focus under Cell and Gene Therapy Access Model
On January 30, the Centers for Medicare & Medicaid Services’ (CMS’) Innovation Center announced that sickle cell disease (SCD) will be the first focus of the Cell and Gene Therapy (CGT) Access Model, a model for eligible states and pharmaceutical manufacturers…
CMS Finalizes CY 2024 Medicare Physician Fee Schedule Rule
On November 2, 2023, the Centers for Medicare & Medicaid Services (“CMS”) released the calendar year (“CY”) 2024 Physician Fee Schedule (PFS) Final Rule (“CY 2024 PFS Final Rule”). The final rule reflects CMS’ broader strategy to promote…
Crowell Health Solutions Examines the Adoption of Decentralized Clinical Trials and Provides Policy Recommendations
On November 28, Crowell Health Solutions published a white paper outlining several policy recommendations to advance widespread adoption of decentralized clinical trials (DCTs). The white paper titled, “Advancing Adoption of Decentralized Clinical Trials: Rationale, Current State, and Policy Recommendations” examines…
FDA Releases Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles
On October 24, 2023, the U.S. Food and Drug Administration (“FDA”), Health Canada, and the U.K.’s Medicines and Healthcare products Regulatory Agency (“MHRA”) jointly released a publication identifying five guiding principles for predetermined change control plans (“PCCP”) for machine learning-enabled…
FDA Issues Final Guidance on Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring
On October 19, 2023, the U.S. Food and Drug Administration (FDA) issued final guidance entitled, “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring,” (the Final Guidance) to provide clarification on its enforcement policies and premarket review…