This weekly news program, hosted by partner Sam Bernstein, covers recent legal and compliance developments for medical device companies, including enforcement actions, guidance documents, and other legal news.
The HHS Office of Inspector General (OIG) issues an unfavorable advisory opinion regarding the provision of a value-added free hearing aid; the OIG issues comprehensive general compliance program guidance; the FDA issues an FAQ regarding providing scientific information on unapproved uses for cleared/approved medical products; and the U.S. Department of Justice continues its fraud enforcement activities in the durable medical equipment space.
A cardiac imaging company and its founder pay $85.48M and enter into a 5 year CIA to resolve allegations that it overpaid referring physicians to supervise PET scans, despite having obtained a fair market value assessment; the president of a laboratory company is sentenced to 8 years in prison and ordered to pay $24M for defrauding investors in a manner similar to the Theranos case and for paying kickbacks to facilitate billing Medicare and other payors for medically unnecessary allergy testing; the FDA updates its enforcement policy regarding non-invasive remote monitoring devices and issues updated guidance regarding premarket notifications for magnetic resonance diagnostic devices as well as for the testing and labeling of medical devices for safety in the MRI environment.
The FDA adopts comprehensive guidance regarding #cybersecurity in Medical Devices; the DOJ continues to prosecute durable medical equipment fraud cases involving fraudulent telemedicine orders; and the FDA implements mandatory electronic submission via the eSTAR Program for 510(k) applications.
A DMEPOS supplier agrees to pay $29M to resolve False Claims Act allegations that it billed Medicare, MA Plans, and beneficiaries for oxygen equipment for which it had already received payment in full; the FDA releases numerous guidance documents regarding 510(k) submissions, the breakthrough device program, and the biological evaluation of medical devices; a participant in a $3.6M durable medical equipment fraud scheme pleads guilty to utilizing telemedicine companies to generate fraudulent orders for medically unnecessary durable medical equipment and soliciting and receiving kickbacks.
The founder of a “brain health” medical device company agrees to pay $445,000 to resolve False Claims Act violations relating to providing erroneous billing and coding advice to his customers; four pharmaceutical companies agree to pay $42.7M to settle alleged Texas Medicaid Fraud Prevention Act violations relating to their nurse educator programs; the FDA issues updated Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors of Human Subject Research.
A number of individuals are charged and sentenced for their involvement in durable medical equipment and related telemarketing fraud; the FDA sends its proposed rule regarding laboratory developed tests (LDTs) to the White House Office of Information and Regulatory Affairs (OIRA) for review; a regulatory affairs specialist pleads guilty to forging false letters from the FDA purporting to show that the FDA had granted clearance to sell two different medical devices; and a manufacturer of hemodialysis machines receives a warning letter regarding its failure to submit a 510(k) or PMA to address the addition of water filtration components to its hemodialysis system.
A former DePuy Synthes sales representative is arrested for allegedly defrauding a hospital into submitting claims for products not actually used in surgery; A number of additional clinics enter into settlements to resolve allegations that they improperly billed Medicare for P-Stim devices, which are non-covered electro-acupuncture devices; the owners of a number of durable medical equipment companies are found guilty or plead guilty to healthcare fraud charges relating to purchasing orders for medically unnecessary durable medical equipment; and the FDA releases draft guidance regarding regulatory submissions for patient-matched guides for orthopedic implants.
A mobile application developer of ovulation and period tracking software agrees to pay civil penalties and 20 years of independent monitoring for violating the Health Breach Notification Rule for sharing sensitive personal health information without consumer notice or consent; A physician is sentenced to 25 years in prison for reusing single-use devices on patients in more than 1500 procedures; the FDA releases final guidance regarding the content of premarket submissions for device software functions, among other topics.
The US Supreme Court rules that, under the Federal False Claims Act (FCA), the knowledge and subjective beliefs of a defendant at the time a false claim was submitted are determinative, and post hoc objectively reasonable rationalizations of that behavior based on an interpretation of an ambiguous law do not excuse the violation; the FDA issues updated draft guidance for good clinical practices (GCP), incorporating the International Council for Harmonisation’s (ICH) recently updated E6(R3) draft guideline; the FDA issues a warning letter with implications for devices that shut off at the end of a subscription or report a limited number of events; the FDA requests public comments on the development of medical technologies for use in non-clinical care settings to advance health equity.
FDA releases updated guidance regarding the Q-Submission Program; C.R. Bard faces an unusual result in its patent dispute with AngioDynamics; A nurse practitioner pleads guilty to committing health care fraud by using protocol orders to order medically unnecessary durable medical equipment (DME); An individual is sentenced to 65 months in prison and ordered to pay over $10M for committing healthcare fraud by fraudulently selling orders for DME; AZ Diabetic Supply, Inc. faces a $12M default judgment for purchasing prescriptions for durable medical equipment.
A medical device manufacturer pays $400,000 to settle claims that it violated the federal Trade Agreements Act (TAA) and made false statements to the Federal government by selling Chinese-made products to the Federal government that were required to have been made in the U.S.; The World Health Organization (WHO) calls for caution in the use of AI programs such as ChatGPT in healthcare; A research study finds that 75% of Class I Recall Notices issued by medical device manufacturers from 2018 to 2022 lacked complete Unique Device Identifiers (UDI).
An ophthalmology medical device distributor loses an Anti-kickback and False Claims Act case and is ordered to pay nearly $490M; the Medical Device Innovation Consortium (MDIC) releases a white paper regarding the #makeCAPAcool framework, which appears to accelerate corrective actions; FDA asks manufacturers to voluntarily notify FDA of manufacturing interruptions and discontinuances despite the end of the Public Health Emergency and asks Congress for the authority to make such notifications obligatory, even in the absence of a public health emergency; fraud and abuse concerns regarding excessive sales representative and distributor compensation are discussed in the context of an alleged Foreign Corrupt Practices Act violation and under the Anti-kickback Statute.
The Federal COVID-19 Public Health Emergency (PHE) Declaration ends May 11th; the former founder and CEO of Nanobeak Biotech, Inc. is sentenced to 48 months in prison for defrauding investors regarding a fake breathalyzer device to detect cancer and narcotics; the FDA issues draft guidance regarding conducting decentralized clinical trials.
A supplier of respiratory durable medical equipment pays $5.3M to resolve False Claims Act allegations; Two physicians receive prison sentences for their roles in a durable medical equipment Medicare Fraud scheme; The FDA posts a warning letter issued to a London-based dental device manufacturer for failing to submit a 510(k) for making changes to their device and for failing to comply with a broad range of regulatory requirements; The FDA posts its updated Data Standards Catalog; The White House Office of Management and Budget begins reviewing a proposal for Medicare coverage of breakthrough devices; the U.S. Department of Commerce issues a proposed rule placing export controls on automated peptide synthesizers.
The EPA issues proposed rules placing limits on the use of ethylene oxide as a sterilizing agent and adopting related record keeping and worker safety requirements; the owner of DME supply companies pleads guilty to conspiracy to commit health care fraud for paying a marketing company for medically unnecessary DME orders procured through telemedicine encounters that were allegedly medically unjustified; the FDA issues Q&A guidance regarding a risk-based approach to monitoring clinical investigations.
Genotox Laboratories agrees to pay $5.9M to resolve False Claims Act and Federal Anti-kickback Statute allegations that it paid commissions to third party marketing firms and independent contractor sales representatives to arrange for laboratory testing; The former CEO, COO, and quality assurance director of Magellan Diagnostics are indicted for allegedly concealing a serious malfunction in their blood lead testing system from the FDA and consumers; Brief discussion of corporate officer liability under the Park Doctrine; The FDA issues draft guidance seeking comments regarding predetermined change control plans (PCCP) to allow for the preapproval of planned modifications to device software functions via machine learning.
The healthcare and life sciences industry chime in on a pivotal Supreme Court False Claims Act case; the Center for Devices and Radiological Health issues guidance regarding the expiration of EUAs and enforcement guidance relating to the COVID-19 pandemic; The Office of Inspector General issues an Advisory Opinion on providing gift cards to patients to encourage them to return a cancer screening test; and the California Division of Occupational Safety and Health issues citations relating to the use of ethylene oxide as a sterilization agent amid a growing battle over EPA-crafted standards.