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Nathaniel Arden

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Nathaniel Arden is a member of Robinson+Cole's Health Law Group. He advises hospitals, physician groups, community providers, and other health care entities on a wide variety of health law and business matters. He regularly assists clients with transactional and regulatory issues, including Medicare and Medicaid fraud and abuse, health information privacy and security, compliance, licensure, clinical trials and health care-related information technology issues. Read his full rc.com bio here.

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Health care providers subject to the Information Blocking rules issued under the 21st Century Cures Act, Pub.L. 114–255, are reminded that such Information Blocking rules will apply to an expanded set of information beginning on October 6, 2022. The Information Blocking rules currently apply only to a limited portion of electronic health information (EHI) represented by the specific data elements identified in the United States Core Data for Interoperability version 1 standard (commonly referred to as USCDIv1). Effective October 6, 2022, the Information Blocking rules will apply to all EHI, which is defined as all electronic protected health information (as defined by HIPAA) to the extent that such electronic protected health information is included in a designated record set (also as defined by HIPAA), and excluding psychotherapy notes and information compiled in reasonable anticipation of, or for use in, a civil, criminal, or administrative proceeding.…

Continue Reading REMINDER: October 6 Deadline for Information Blocking Rules Approaches

As we have previously written on, Connecticut Governor Ned Lamont recently signed into law the state’s budget as Public Act 22-118 (Act), which makes various changes to the Connecticut statutes. Among the changes, the Act expands the authority of Connecticut’s Office of Health Strategy (OHS).…

Continue Reading Connecticut Expands OHS Authority

As part of Connecticut’s budget implementer bill (Act) signed into law earlier this month, the state made significant revisions to its laws concerning collaborative drug therapy management agreements between pharmacists and certain prescribing practitioners to expand the (1) types of permitted arrangements; (2) prescribers eligible to participate in the collaborative arrangements with pharmacists; and (3) scope of pharmacists’ authority under these arrangements. These revisions are effective as of July 1, 2022.…

Continue Reading Connecticut Makes Significant Changes to its Collaborative Drug Therapy Laws

On May 7, 2022, Connecticut Governor Ned Lamont signed into law the state’s fiscal year 2023 budget (HB5506) (Act) which implements the state budget and makes various changes to certain Connecticut statutes. Among the changes, the Act provides various new authorities to the Office of Health Strategy (OHS) and makes modifications to the certificate of need (CON) process in the state.…

Continue Reading New Connecticut Laws Include Certificate of Need Changes

On May 7, 2022, Connecticut Governor Ned Lamont signed into law the state’s fiscal year 2023 budget (HB5506), which includes the elimination of certain taxes on ambulatory surgical centers (ASCs) in Connecticut. Since October 1, 2015, ASCs have been required to pay a quarterly tax of six percent on their gross receipts (subject…

On April 27, 2022, the Office of Inspector General (OIG) published Advisory Opinion 22-08 (Advisory Opinion) in which it declined to impose sanctions against a federally qualified health center (Requestor) for an arrangement involving the loaning of smartphones to patients to allow those patients to receive telehealth services from the Requestor. The OIG concluded that although the arrangement would constitute prohibited remuneration under the Federal anti-kickback statute (AKS) and the beneficiary inducement prohibitions of the Civil Monetary Penalties Law (CMP), the limited scope of the arrangement and the safeguards in place did not warrant the imposition of sanctions.
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Continue Reading Advisory Opinion 22-08: OIG Declines to Impose Sanctions for Loaning of Smartphones for Receipt of Telehealth Services

The Office of Inspector General (OIG) recently created a new webpage related to telehealth. The purpose of the webpage is to summarize the OIG’s telehealth oversight work to provide a summary of its findings and recommendations that can be used by policymakers and other stakeholders to evaluate potential changes to federal telehealth policies.
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Continue Reading OIG Creates New Telehealth Resources Webpage

On March 24th, 2022, the Advanced Medical Technology Association’s (AdvaMed) Board of Directors approved updates to the AdvaMed Code of Ethics (Code), which provides guidance to the health care industry on interactions between medical technology companies and health care professionals (HCPs). The revised Code goes into effect on June 1, 2022.
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Continue Reading AdvaMed Updates its Code of Ethics

On March 30, 2022, the United States Department of Justice (DOJ) announced that Manual J. Bojorquez, the owner of a marketing company, was sentenced to 36 months’ probation and ordered to pay restitution of $3.3 million for his role in a kickback scheme. The sentencing follows a plea agreement by Mr. Bojorquez in which he pleaded guilty to conspiracy to violate the federal anti-kickback statute. According to the DOJ and court documents, Mr. Bojorquez, through his company, provided marketing services to various compounding pharmacies. Mr. Bojorquez’s company conspired with the compounding pharmacies to pay kickbacks to physicians in exchange for those physicians referring prescriptions to the compounding pharmacies. The compounding pharmacies then paid Mr. Bojorquez (through various shell companies) a percentage (approximately 45%) of the fees generated from the prescriptions referred by the physicians. The pharmacies billed and received payment from the US Department of Labor’s (DOL) Office of Workers Compensation Program, which is a federal health care benefit program. Over the course of the conspiracy, the DOL paid over $8 million for the kickback-induced prescriptions.
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Continue Reading Marketer in Kickback Scheme Involving Compound Pharmacies Sentenced to Probation and Order to Pay $3.3 Million

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 certain cost-sharing obligations of clinical trial participants, including Medicare beneficiaries. The OIG concluded that although the proposed arrangement (described below) would constitute prohibited remuneration under the Federal anti-kickback statute (AKS) and the beneficiary inducement prohibitions of the Civil Monetary Penalties Law (CMP), the low-risk nature of the proposed arrangement did not warrant the imposition of sanctions.
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Continue Reading Advisory Opinion 22-05: OIG Declines to Impose Sanctions Against Device Manufacturer’s Medicare Cost-Sharing Subsidy in Clinical Trial