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OIG Alert and DOJ Enforcement Action Summary: Telemedicine Arrangements

The July 20, 2022 Special Fraud Alert describes findings from what OIG describes as “dozens of investigations of fraud schemes involving companies that purported to provide telehealth, telemedicine, or telemarketing services”...more

Taking Security Interests in Human Reproductive Tissue: Clarifying Lender Options under Federal and State Law

Can human reproductive tissue (“HRT”) held by a fertility clinic serve as collateral for a loan to (or investment in) the fertility clinic? In short, the scope and extent of governmental regulation addressing the sale of or...more

President Biden Signs Into Law Medicare Telehealth Coverage Extension Post-Public Health Emergency

On March 15, 2022, President Biden signed into law the $1.5 trillion Consolidated Appropriations Act of 2022 (the “Omnibus Bill”). Included in the 2,700+ page Omnibus Bill is an extension of Medicare coverage of professional...more

DOJ False Claims Act Recoveries Exceed $5.6 Billion in 2021

The U.S. Department of Justice (“DOJ”) recently announced that over $5.6 billion in False Claims Act (“FCA”) settlements and judgments had been reached during the 2021 fiscal year, with over $5 billion of those settlements...more

CMS Continues to Modernize by Expanding Reimbursement for Digital Health Services

The COVID-19 Public Health Emergency (“PHE”) fundamentally changed the healthcare industry, forcing healthcare providers and patients onto their computers and phones to enable continuation of care when patients were mandated...more

California Physicians Allege PE-Backed Provider Violates Corporate Practice Law

On December 20, 2021, a group of emergency medicine physicians in California filed suit against a private equity-backed health care services company, claiming that (among other things), the company has run afoul of the...more

Medicare Agrees to Limited Payment for New Alzheimer’s Drug

On January 11, 2022, the Centers for Medicare and Medicaid Services (CMS) released a proposed National Coverage Determination (NCD) decision memo limiting Medicare coverage for Biogen’s new Alzheimer’s drug, Aduhelm. Under...more

Senate Judiciary Committee Advances False Claims Act Amendment to Full Senate

On October 28, a majority of members on the Senate Judiciary Committee voted 15-7 to advance to the full Senate a bipartisan bill that would make a number of amendments to the False Claims Act (“FCA”), including one that...more

Heating Up: Federal Sunshine Act Enforcement on the Rise

After several years without any enforcement, the U.S. Department of Justice (“DOJ”) recently penalized medical device and life sciences companies for violating the U.S. Provider Payments Sunshine Act (“Sunshine Act”) (42...more

OIG Advocates for Increased Oversight of Medicaid Telehealth Services in Behavioral Health

Telehealth’s exponential growth –in part due to the COVID-19 pandemic – has highlighted both its value in increasing access to care and the potential for misuse. The U.S. Department of Health and Human Services’ Office of...more

Pharmaceutical Manufacturers Beware: New State Drug Transparency Laws and Enforcement Mechanisms Are Coming In 2022

In 2016, states began passing pharmaceutical price reporting laws. These laws are designed to bring transparency to a pharmaceutical manufacturer’s drug pricing process by requiring drug manufacturers to report pricing and...more

Attention Pharmaceutical Manufacturers: New State Drug Transparency Laws and Enforcement Mechanisms Are Coming In 2022

In 2016, states began passing pharmaceutical price reporting laws. These laws are designed to bring transparency to a pharmaceutical manufacturer’s drug pricing process by requiring drug manufacturers to report pricing and...more

Don’t Forget about the States! Understanding the Maze of State Billing Laws for Physicians and Laboratories Providing Anatomic...

Laboratory tests play a critical part of the healthcare system. Ordering and billing for these tests, however, is not always cut-and-dry. Compliance with federal laws and rules (like the Clinical Laboratory Improvement...more

Judge Dismisses Pfizer’s Lawsuit Over HHS Limits on Drug Copay Assistance

In a previous post published on the Washington Legal Foundation’s Legal Pulse blog, Goodwin Partners Matt Wetzel and William Jackson discussed the potential implications of a high-profile recent lawsuit lodged by Pfizer...more

Exactly One Year Later, CMS Reverses Course on Covering Innovative MedTech

In September 2020, the Centers for Medicare & Medicaid Services (CMS) proposed a new rule that would expedite Medicare coverage for medical technology approved through the Food & Drug Administration’s (FDA’s) “Breakthrough...more

Florida Joins List of States Requiring Licensure for Genetic Counselors

Many allied health professionals are subject to state-level licensing requirements that can vary from jurisdiction-to-jurisdiction. What may be required in New York to hold a medical professional license may differ...more

Mitigation of Cybersecurity Risks in Medical Device Software: FDA Discussion & Insights for OEMs, Remanufacturers, and Servicers

I. OVERVIEW - The U.S. Food & Drug Administration (“FDA”) has increased its focus on mitigating cybersecurity risks in medical device software. On June 24, 2021, the FDA issued two documents that are important not only...more

Alere Pays $198.75 Million to Settle False Claims for Allegedly Billing Medicare for Defective POC Devices, Not Charging Copays,...

Alere Inc. and Alere San Diego Inc. (collectively “Alere”) have come under fire recently by the U.S. Department of Justice (“DOJ”) and other government agencies, agreeing to settle several rounds of accusations of False...more

Patient Stakeholder Group Zeroes in on Medical Device Industry

In recent months, the Kaiser Health Network (part of the Kaiser Family Foundation) has issued three reports scrutinizing the orthopedic industry and its practices. Each report articulates the stakeholder group’s concerns over...more

PhRMA Issues Updates to Longstanding Code, Addresses OIG’s Speaker Program Guidance

PhRMA, the pharmaceutical manufacturer trade association, announced on Fri. August 6 that it has revised its longstanding Code on Interactions with Health Care Professionals. The revisions, which relate to the Code’s...more

CMS Proposes Important New Updates to the Sunshine Act’s Open Payments Program

The Centers for Medicare & Medicaid Services (CMS) released its proposed 2022 Physician Fee Schedule rule (Proposed Rule) on July 13, 2021. Included in the rule are several proposed updates to the CMS Open Payments Program,...more

Biden Executive Order Targets Competition in Healthcare, Life Sciences to Spur Economic Activity

On July 9, 2021, President Joe Biden issued an Executive Order (the “Order”) designed to promote competition in the American economy. The Order describes the administration’s concerns with competition in several markets,...more

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