Health Care Law Brief

NOVEMBER 30, 2021

In an advisory opinion posted November 10, 2021 ( AO 21-15 ), the Office of the Inspector General of the United States Department of Health and Human Services (OIG) appeared to soften a disturbing position that it had taken in 2012 regarding the employment safe harbor.

Medicare 40

Medicare Medicare Regulatory Compliance Fraud 40

HIPAA Journal

MAY 18, 2023

The Department of Health and Human Services’ Office for Civil Rights is the main enforcer of HIPAA compliance; however, state Attorneys General also play a role in enforcing compliance with the Rules of the Health Insurance Portability and Accountability Act (HIPAA). 2022 New York EyeMed Vision Care $600,000 2.1 million 78.8

HIPAA 96

HIPAA Compliance Ransomware Hospitals 96

Innovaare Compliance

FEBRUARY 9, 2021

The Affordable Care Act of 2010 mandates the CMS to make quality bonus payments (QBPs) to Medicare Advantage (MA) organizations that achieve at least four stars in a 5-star quality rating system and, starting in 2012, the CMS incentivizes health plans to improve member experiences by increasing the QBP amount, based on their star rating.

Medicare 40

Medicare Medicare Medicaid Medicaid 40

New Jersey Healthcare Blog

JULY 22, 2022

Following a thorough review in compliance with Executive Order No. In 2012, N.J.S.A. These include the purpose and scope, definitions, standard of care, licensee-patient relationship, provision of health care services through telemedicine or telehealth, records, prevention of fraud and abuse, and privacy and notice to patients.

COVID-19 Vaccine 40

COVID-19 Vaccine Licensing COVID-19 Public Health 40

Drug & Device Law

AUGUST 8, 2022

The unfortunate truth is that ECFMG was also a victim of this fake doctor’s fraud. So if compliance with an industry standard is a defense, this plaintiff went a step further and sued the organizations that created the standards. 2012 WL 3265002, at *5 (N.D. has no power to enforce compliance”), aff’d , 405 F.

Doctors 52

Doctors Fraud Licensing Compliance 52

Drug & Device Law

JANUARY 30, 2023

470 (1996), was decided – removing express preemption as a defense for manufacturers of §510(k) products So defendants moved on fraud on the FDA under an implied preemption theory and won. Mensing , 564 U.S. Mensing , 564 U.S. Lohr , 518 U.S. Davidowitz , 312 U.S. Davidowitz , 312 U.S.

FDA 72

FDA Fraud Governance Medicare 72

Drug & Device Law

FEBRUARY 15, 2024

2022) (recognizing the following product defect liability theories: “(1) negligent design of the product; (2) negligent manufacture of the product; (3) negligent failure to warn about some aspect of the product; (4) breach of express or implied warranty; or (5) misrepresentation or fraud”). 2d 279, 287 (Mich. 2946(4).

FDA 52

FDA Compliance Fraud Hospitals 52

Drug & Device Law

MAY 5, 2022

The court further explained that, “[t]o overcome this presumption,” which has been called the “compliance presumption, “a plaintiff must plead specific facts alleging ‘deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects, or manipulation of the post-market regulatory process[.]’” Id. 2012), and Garcia v.

Compliance 52

Compliance FDA Fraud 52