Hospice Insights Podcast - Election Inspection: Be Proactive to Avoid Costly Election Statement Denials
(Podcast) California Employment News – Key Rules for California Employers: Business Expense Reimbursement
California Employment News – Key Rules for California Employers: Business Expense Reimbursement
AGG Talks: Home Health & Hospice - Reimbursement Audits and Appeals
Podcast: Direct Access Laboratory Testing: Reimbursement & Compliance – Diagnosing Health Care
Podcast: Owner's Outlook: Maximize and Safeguard Reimbursement Through Design - Diagnosing Health Care
HealthLaw HotSpot - A Look at Alternative Reimbursement Models in Value-Based Care
The Important and Thriving Role of Private Medical Practices
Value-Based Care and Its Impact on Providers
The Year Ahead: Litigation Hot Spots at a Glance
Teleworking: Amazing or amazingly complex?
(Video) Reimbursement of College Tuition and Fees After COVID-19
Value-based health care: compliance infrastructure
K&L Gates Triage: 340B Eligibility - Hospital Covered Entities
Value-based health care: fraud & abuse laws
Value-based health care: issues for pharmaceutical companies
Condo Water Invasion: Potential Medical Liability?
Recent activity among lawmakers and federal agencies signal that the government may be poised to undertake meaningful legislative and administrative efforts to harness the potential of digital health innovation and to expand...more
The Centers for Medicare & Medicaid Services (CMS) have released significant updates affecting Medicare payments for 2025. The changes, outlined in two final rules, will impact both physicians and hospitals, eliciting strong...more
Obtaining Medicare coverage and reimbursement for medical devices is notoriously more difficult than for drugs or biologics, and any progress on expanding coverage pathways has been agonizingly slow for industry stakeholders....more
On June 28, the US Supreme Court overturned the Chevron doctrine — the legal principle that the judiciary should defer to a federal agency’s reasonable interpretation of an ambiguous statute. Chevron reflected the view...more
Earlier this year, we reported on the expected U.S. Food and Drug Administration (FDA) ruling concerning Laboratory Developed Tests (LDTs). The FDA has consistently shown a commitment to regulating LDTs. On May 6, 2024, the...more
In recent years, the Centers for Medicare & Medicaid Services (CMS) has expanded payment for remote monitoring services in an effort to pay for non-face-to-face services that improve care coordination for Medicare...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for July 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more
Sophisticated clinical software systems employed in specific health care services have graduated from being interfaces, operating systems, and subordinate tools that support physical medical devices and have matured to the...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. This week's topics include ...more
As the nomination of Dr. Robert Califf to head the federal Food and Drug Administration advances, he and the agency already are confronting a major regulatory crisis over Aduhelm, a prescription drug targeted for Alzheimer’s...more
On November 19, 2021, OIG issued Advisory Opinion No. 21-17 in which it responded to a request for an advisory opinion regarding a proposed subsidization of certain Medicare cost-sharing obligations in the context of a...more
Breaking News- New Leadership at the FTC- •President Joseph R. Biden designated Federal Trade Commission (“FTC”) Commissioner Rebecca Kelly Slaughter as Acting Chair of the FTC . •As Commissioner, Chairwoman...more
This month, HHS released over twenty new and modified Frequently Asked Questions (FAQs) regarding payments distributed to providers via the CARES Act Provider Relief Fund. The FAQs cover a wide range of topics, including...more
In Washington: State public health officials are urging Congress to provide at least $8.4 billion in emergency funding for distributing a coronavirus vaccine, warning that they lack enough money to carry out the immense...more
Life Beyond FDA Clearance or Approval: The Reimbursement Challenge - To medical device manufacturers, winning premarket approval or 510(k) clearance from the U.S. Food and Drug Administration (FDA) is only half the battle....more
Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more
In the wake of a new Medicare reimbursement framework, FDA plans stricter regulation of some in vitro diagnostic devices. On July 31, 2014, the U.S. Food and Drug Administration (FDA; Agency) announced its intent to...more