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
In the wake of the 2024 U.S. elections, stakeholders in the life sciences and health care industry are intensely focused on the policy implications for global financial markets, investment strategies, and M&A opportunities....more
Healthcare in the United States is undergoing significant changes, particularly in the areas of reimbursement and coverage of telehealth, substance use disorders (SUDs), and mental health services. The proposed 2025 Physician...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
The U.S. Department of Health and Human Services Office of Inspector General (HHS OIG) recently issued Advisory Opinion No. 24-04, which primarily addressed a Refund Program offered by a U.S. pharmaceutical company affiliate....more
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
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
Pharma’s favorite summer pastime is back again: reviewing the Centers for Medicare & Medicaid Services (CMS) release of the 2025 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS)...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
Wilson Sonsini’s 31st Annual Medical Device & Digital Health Conference will address topics of critical importance to medical device and digital health companies, including early and late-stage venture financing, partnering...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
Schmidt v. Schmidt, Kirifides & Rassias, Pa. C. (WCAB); No: 1039 C.D. 2021; filed Nov. 14, 2023; Judge Covey - In this case, the claimant, an attorney, sustained a work injury on April 14, 2017, while loading files into a...more
The U.S. Food and Drug Administration (FDA), in collaboration other agencies, recently published draft guidance (Guidance) on effectively presenting key information regarding informed consent in FDA-regulated clinical...more
Illumina Agrees to Unwind Acquisition of Grail Following Fifth Circuit Decision. On December 15, 2023, the Fifth Circuit vacated the FTC’s order that Illumina unwind its acquisition of Grail—a developer of a multi-cancer...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
Nearly nine years to the day the Food and Drug Administration (FDA) issued a draft “information sheet” on informed consent, the agency published a 66-page final guidance document on the topic—marking the first time since 1998...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
Editor’s Note: We are excited to announce that this article is the first of a series addressing Software as a Medical Device and the issues that plague digital health companies, investors, clinicians and other organizations...more
On May 2, 2023, the U.S. Food and Drug Administration (FDA) released Draft Guidance regarding the implementation of Decentralized Clinical Trials (DCTs) for drugs, biological products, and devices. DCTs are clinical trials...more
Advanced Bionics Corporation—a manufacturer and distributor of cochlear implants—entered settlements with six AGs to resolve allegations that the company violated federal and state False Claims Acts by submitting fraudulent...more
+Dx Forum 2023 is the premier gathering for the laboratory diagnostics community. Join us for insightful discussion about the latest regulatory and reimbursement developments....more
DOJ Indicts 47 Individuals in Largest COVID-19 Fraud Scheme To Date - On September 20, 2022, the US Department of Justice (“DOJ”) announced federal criminal charges against 47 defendants from the nonprofit, Feeding Our...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 of January 15, 2022, fully-insured and self-insured group health plans are required to reimburse participants for the cost of purchasing over-the-counter (“OTC”) COVID-19 tests, even if such tests are purchased without the...more