Below is an excerpt of a contributed article co-authored with Robinson+Cole Business Litigation Group lawyer Ben Daniels published in Physicians Practice on September 16, 2022.

On July 25, 2022, the U.S. Court of Appeals for the Second Circuit rejected an appeal brought by Pfizer, Inc. in a case that examines whether a “corrupt” intent is required to violate the Anti-Kickback Statute (AKS). The decision addressed a proposed direct copayment assistance program of a pharmaceutical manufacturer which sought to help patients pay for an expensive drug, and whether such a program may be subject to sanctions under the AKS’ prohibition on transfers of remuneration inducing referrals of drugs and other items or services reimbursed by federal health care programs. Funding of copayment assistance programs by pharmaceutical manufacturers to increase access to drugs for certain conditions has become a common practice following prior governmental guidance sanctioning the practice as long as certain safeguards are in place, but the Pfizer program posed a distinct issue for the government because the program provided direct assistance to patients looking to purchase Pfizer’s own drug. In short, the government has concerns that without sufficient independence and safeguards in place, such assistance programs can become alleged conduits for improper payments from pharmaceutical manufacturers to patients to influence purchase of the manufacturers’ drugs. Read the article.

Mark Schena, the President of Arrayit Corporation, has been found guilty by a jury for violations of the Eliminating Kickbacks in Recovery Act (EKRA), healthcare fraud, wire fraud, and securities fraud.

Continue Reading A COVID-19 Laboratory Testing Conviction under EKRA

On August 19, 2022, the Office of Inspector General (OIG) published Advisory Opinion 22-16 (Advisory Opinion) in which it declined to impose sanctions for an arrangement under which the requestor provides gift cards to patients for completing an online learning program related to surgeries. 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), it is unlikely to impact competition among providers or influence selection of a particular provider and therefore determined that the arrangement did not warrant the imposition of sanctions.

Continue Reading Advisory Opinion 22-16: OIG Declines to Impose Sanctions for Arrangement Involving Provision of Gift Cards to Patients for Completing Learning Program

The Department of Health and Human Services Office of Inspector General (OIG) recently released a Data Brief summarizing the findings of a review of program integrity risks related to telehealth services reimbursed by Medicare during the first year of the COVID-19 pandemic (the Pandemic).[1] The OIG analyzed Medicare and Medicare Advantage claims data from March 1, 2020, to February 28, 2021, focusing on providers that billed for telehealth services, with an emphasis on identifying providers that posed a high risk to the Medicare program.

Continue Reading OIG Releases Data Brief on Medicare Telehealth Program Integrity Risks During the First Year of the Pandemic

On August 18, 2022, New Jersey Governor Phil Murphy signed S-315, “An Act concerning changes in control of health care entities” (the Act). The Act implements employment protection for healthcare workers when certain licensed health care facilities, staffing registries, and home care services in New Jersey undergo a change in ownership. The Act first requires that former health care entity employers provide the successor health care entity with information pertaining to employees (i.e., employee names, addresses, dates of hire, phone numbers, wage rates, employment classifications) not less than thirty days before a change in control. The Act also requires former health care entity owners to inform eligible employees of the rights provided by the Act and to post a notice of their rights under the Act in a conspicuous location.

Continue Reading New Jersey Governor Signs Act Concerning Changes in Control of Health Care Entities

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

On August 19, 2022, the Department of Health and Human Services (HHS), Department of Labor (DOL), and Department of the Treasury (DOT), released “Requirements Related to Surprise Billing: Final Rules” (the Rules). The Rules change and finalize the prior interim final rules concerning the information health insurers must share regarding the qualifying payment amount (QPA) and the independent dispute resolution (IDR) process under the No Surprises Act.  The Rules address comments received pertaining to the interim final rules as well as the recent judicial decisions in Texas Medical Association[1]and LifeNet. [2]

Continue Reading New Final Rule Under the No Surprises Act Released

HHS-OIG issued a new Special Fraud Alert on relationships with “purported telemedicine companies” on July 20, 2022. The Special Fraud Alert comes on the heels of a nationally coordinated takedown charging dozens of individuals criminally for their participation in an allegedly fraudulent scheme related to telemedicine, laboratories, and durable medical equipment (“DME”).[1] However, the alert comes after focus on telemedicine fraud cases in particular since 2019. The Special Fraud Alert identifies several characteristics of concern and common elements that individuals and companies should be aware of.

Continue Reading Suspect Characteristics Identified under a Telehealth Special Fraud Alert

According to the 2022 State of Ransomware Report issued recently by Sophos, it surveyed 5,600 IT professionals from 31 countries, including professionals in the health care sector. Those professionals in the health care sector shared that 66 percent of them had experienced a ransomware attack in 2021, which was an increase of 69 percent over 2020. This was the largest increase of all sectors surveyed.

Continue Reading Privacy Tip – Health Care Sector Continues to Be Hit with Ransomware

The Department of Health and Human Services (HHS) Office for Civil Rights (OCR) recently issued new guidance (Guidance) on the use of remote communication technologies to deliver audio-only telehealth in accordance with HIPAA. Per OCR, the Guidance is intended to ensure continued access for patients to audio-only telehealth in a secure and compliant manner, particularly once OCR’s notification of enforcement discretion (previously discussed here) tied to the COVID-19 pandemic is rescinded (i.e., once the HHS-declared COVID-19 public health emergency is ended).

Continue Reading HHS Issues HIPAA Guidance to Support Audio-Only Telehealth Services