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?
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
Below is Part II of our New Jersey Statutory update. As you can see from the below, several statutes were passed imposing requirements on health insurance payers, including new requirements for prior authorization request and...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
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
On November 2, 2023, the Centers for Medicare & Medicaid Services (CMS) finalized new policies related to remote physiologic monitoring (RPM) and remote therapeutic monitoring (RTM) services reimbursed under the Medicare...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for August 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
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
The third quarter of 2022 brought a number of noteworthy False Claims Act (FCA) settlements, including several over $20 million and one in the high nine figures. This post summarizes key settlements of interest to healthcare...more
On March 11, 2022, OIG issued Advisory Opinion No. 22-05 in which it responded to a request for an advisory opinion regarding a proposed subsidization of certain cost-sharing obligations in the context of a clinical trial...more
On March 16, 2022, the Office of Inspector General (OIG) published Advisory Opinion 22-05 (Advisory Opinion) in which it declined to impose sanctions against a medical device manufacturer (Requestor) that proposes to pay...more
On July 9, 2021, the Delaware Court of Chancery (Slights, V.C.) issued an opinion in Bardy Diagnostics, Inc. v. Hill-Rom, Inc., No. 2021-0175-JRS, concluding that the requirements of a “material adverse effect” (“MAE”) clause...more
In this month’s update, state high courts consider reimbursement of defense costs, reimbursement of medical marijuana costs, and reimbursement of ransomware payments. Federal courts determine whether a debt collector is...more
This week, we examine two decisions confronting novel procedural issues. In the first, the Ninth Circuit sought to promote development of the law by encouraging courts to alter how they address claims under the Fair Credit...more
Health apps and other digital medical devices are making increasingly important contributions to healthcare. While in the past such medical devices were reimbursed by statutory health insurance funds on a case-by-case basis...more
The World Health Organization (WHO) has determined that the 2019 novel coronavirus is a “global pandemic” and President Trump has declared a national emergency as the impact of the virus on all aspects of daily life continues...more
Introduction In November 2019, the parliament passed a new law which will provide reimbursement for digital healthcare provision for the around 70 million publicly insured patients in Germany (Digital Health Service...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
There will always be differences among state laws on telehealth coverage, but what is remarkable is the rapidly increasing pace at which states have been adopting coverage statutes in the last few years, with currently 29...more
The continued development and refinement of personalized medicine (PM) has offered an opportunity to revolutionize medical practice and improve outcomes by providing treatments for patients with the notion that “this drug is...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
As the Healthcare Landscape Shifts, Four Issues Are Critical to Build Effective Market Access Strategies - In this time of high growth and fast change for the healthcare industry, pharmaceutical, biotechnology and...more