Health Care

January 22, 2020

Earlier this week the CDC confirmed the United States had its first case of a deadly new strain of coronavirus “2019-nCoV.” The patient is from Washington state and was returning to the United States from Wuhan, China. At least seventeen people in China have died from the coronavirus. In a press release, the CDC stated that “[w]hile originally thought to be spreading from animal-to-person, there are growing indications that limited person-to-person spread is…

C&M Health Law

Crowell & Moring Releases Litigation Forecast 2020 — Federal Agencies and Private Plaintiffs Turn Attention to Disability Issues

By Crowell & Moring

January 22, 2020

Crowell & Moring has released Litigation Forecast 2020: What Corporate Counsel Need to Know for the Coming Year. The eighth-annual Forecast provides forward-looking insights from leading Crowell & Moring lawyers to help legal departments anticipate and respond to challenges that might arise in the year ahead. For 2020, the Forecast focuses on how the digital revolution is giving rise to new litigation risks, and it explores trends in employment non-competes, the future of stare…

Medicaid and the Law

CMS Is Seeking Guidance on Medicaid Coverage for Children Provided Across State Lines

By Thomas Barker

January 22, 2020

The Medicaid program generally has more generous coverage rules for children than for adults. For example, under the Early and Periodic Screening, Diagnostic and Testing (EPSDT) provisions of the Medicaid statute, if a child’s medical condition is identified via an EPSDT screening, the state’s Medicaid plan must cover treatment for that condition, even if the necessary treatment consists of an optional benefit under the state Medicaid plan. But what happens if the state where…

Triage Health Law

HHS OIG Flags $2.2 Billion in Potential Medicare Advantage Overpayments for CMS Audits

By Sven Collins & Colin Jennings

January 21, 2020

CMS said it plans to audit risk-adjustment payments that Medicare Advantage (MA) plans received based on having identified additional diagnoses in beneficiary medical chart reviews. CMS’s action was spurred by a recent report from the HHS Office of Inspector General (OIG) entitled, “Billions in Estimated Medicare Advantage Payments From Chart Reviews Raise Concerns.” (Click here for the report). As the OIG’s report explains, MA insurers receive risk-adjustment payments, based in part on diagnoses, to account…

Pharma in Brief

Health Canada Provides Guidance on Regulation of Software as a Medical Device (SaMD)

By Caroline Henrie, David Yi & Jordana Sanft

January 21, 2020

On December 18, 2019, Health Canada published a new Guidance Document Software as a Medical Device (SaMD): Definition and Classification (Guidance Document). The Guidance Document explains what products would be regulated as SaMD under the Food and Drugs Act (Act) and the Medical Devices Regulations (Regulations) as well as information on classification of SaMD. What Constitutes SaMD Not all software falls within the scope of the Act and Regulations. The Guidance Document provides current interpretations…

The Healthcare Investor

Women in PE to Know: Katie Harris Storer

By Amber Walsh

January 21, 2020

McGuireWoods has long been an avid supporter of the advancement of professional women. As part of our initiative seeking to expand the leadership of women in private equity, we are continuing our series of profiling women leaders in private equity. We are hopeful that this series will serve to inspire other women to pursue their careers in private equity in a way that best challenges and motivates them, which these impressive women have all done.…

DC Medical Malpractice & Patient Safety Blog

FDA reviews go faster — but with less proof drugs are safer or more effective

By Patrick A. Malone

January 21, 2020

For anyone concerned with the quality and safety of prescription medications, this may be an especially displeasing commentary from a pharmaceutical expert about drugs raced to approval now: “Some of them are really great,” the professor observed. “And some of them [are] not so great. And a lot of them are very expensive.” That quote, by the way, comes from a news report by NPR on so-called reforms of the federal Food Drug and…

Legionnaire's Disease News

Carol Stream outbreak: 3 stricken, 2 dead in Illinois

By News Services

January 21, 2020

Carol Stream outbreak: 3 stricken, 2 dead in Illinois — Carol Stream outbreak: Two retirees have died and a third was sickened in a Legionnaires’ disease outbreak being investigated by Illinois health officials. Carol Stream is a village of about 40,000 people in DuPage County, about 34 miles west of the Chicago Loop.

Elliot Olsen has regained millions for people harmed by Legionnaires’ disease. If you or a family member were affected by this Carol Stream outbreak, please call Elliot at (612) 337-6126 for a free consultation. Two Carol Stream retirement home residents have died, and a third was sickened, in a Legionnaires’ disease outbreak being investigated by Illinois health officials. Officials for the Covenant Living at Windsor Park retirement home did not release any other information on…

Health Law Pulse

DOJ Recovers More than $2.6 Billion from Health Care False Claims Act Cases in FY 2019

By Keith Rosen (US) & Chandra Westergaard (US)

January 21, 2020

On January 9, the United States Department of Justice (“DOJ”) announced its statistics on federal False Claims Act cases for FY 2019. In a lengthy press release, the DOJ reported more than $3 billion in settlements and judgments from civil cases involving fraud and false claims against the government. Of this total, the DOJ reported that $2.6 billion – approximately 87% — derived from matters that involved the health care industry. The data released by…

Life Sciences Legal Update

Please join us for an upcoming CLE Webinar, “Digital Health 101”

By Lisa Baird

January 21, 2020

On Thursday, January 23, 2020 at 12:00 PM ET, Reed Smith will be hosting “Digital Health 101”, a CLE webinar covering: Federal and state health care regulatory and reimbursement issues, including fraud and abuse implications and insurance coverage for digital health devices and services Applicability of federal and state privacy laws, including the Health Insurance Portability and Accountability Act (HIPAA), Telephone Consumer Protection Act (TCPA), California Consumer Privacy Act (CCPA), biometric privacy laws, and Federal…

Health Care

U.S. Prepares for Deadly Coronavirus

Crowell & Moring Releases Litigation Forecast 2020 — Federal Agencies and Private Plaintiffs Turn Attention to Disability Issues

CMS Is Seeking Guidance on Medicaid Coverage for Children Provided Across State Lines

HHS OIG Flags $2.2 Billion in Potential Medicare Advantage Overpayments for CMS Audits

Health Canada Provides Guidance on Regulation of Software as a Medical Device (SaMD)

Women in PE to Know: Katie Harris Storer

FDA reviews go faster — but with less proof drugs are safer or more effective

Carol Stream outbreak: 3 stricken, 2 dead in Illinois

DOJ Recovers More than $2.6 Billion from Health Care False Claims Act Cases in FY 2019

Please join us for an upcoming CLE Webinar, “Digital Health 101”

Health Care Blogs

Stay Connected

Company

Support

New to the Network