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
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.
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
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
On June 2, 2022, the New York State Legislature passed A08472, “An Act to Amend the Public Health Law, in Relation to the Establishment, Incorporation, Construction, or Increase in Capacity of For-Profit Hospice” (“the Act”). The Act prohibits the Public Health and Health Planning Council (PHHPC) of the New York Department of Health (DOH) from approving any new applications for the establishment, incorporation, or construction of a for-profit hospice. Additionally, the bill prohibits PHHPC from approving any increases in capacity to existing for-profit hospices in the state. The two current for-profit hospices will remain approved but cannot expand capacity. The Act will now be presented to the Governor for signature. Once signed by the Governor, the Act will become effective immediately.
Continue Reading New York State Legislature Passes Act Enacting Moratorium on For-Profit Hospices
The New York State Department of Health (DOH) recently released a “Dear Administrator Letter” (DAL) DHCSB 22-02 for Licensed Home Care Services Agencies (LCHSAs). The DAL addresses guidance and procedures for LCHAs as they relate to certain administrative licensure amendments. Such amendments include changing the service, county of operation, sites, address of agency or operator, the corporate name or assumed name (d/b/a), or closing a site.
Continue Reading New York State Department of Health Releases Administrative Guidance for LCHSAs’ Licensure Amendments
I. Biden Administration Requirement for Insurance Companies to Cover Cost of At-Home COVID-19 Tests
On January 10, 2022, the U.S. Department of Health and Human Safety (HHS) announced that the Biden-Harris administration will be requiring insurance companies and group health plans to cover the cost of over-the-counter, at-home COVID-19 tests, so people with private health coverage can get them for free starting January 15, 2022. This new coverage requirement means that most consumers with private health insurance will be able to purchase an at-home COVID-19 test (online or at a pharmacy) and it will either be paid for directly by their health plan or the consumer can submit a claim for reimbursement.
Starting January 15, 2022, insurance companies and health plans will be required to cover eight (8) free over-the-counter at-home tests per covered individual per month, and there will be no limit on the number of tests that are covered if they are ordered or administered by a health care provider following an individualized clinical assessment.
As part of the new requirement, the administration is incentivizing insurers and group health plans to create programs that allow people to get the over-the-counter tests directly through preferred pharmacies, retailers, or other entities with no out-of-pocket costs. Retailers and other entities providing access to consumers for over-the-counter testing should be aware of the requirements. Even if plans and insurers make tests available through preferred pharmacies or retailers, such plans and insurers are still required to reimburse tests purchased by consumers outside of that network, at a rate of up to $12 per individual test (or, if less, the cost of the test)
Continue Reading New COVID-19 At-Home Test Coverage Requirements Increase Need for Heightened Focus on Health Care Entity’s Billing Practices
On Monday, November 15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to enforce premarket review requirements for COVID-19 laboratory developed tests (LDTs). This prior policy, which waived premarket review requirements aimed at increasing broad public access to COVID-19 tests, was generally consistent with the FDA’s historical stance allowing laboratories to not seek approval of LDTs. With the policy announced by the Trump administration, laboratories again began offering their tests prior to or without an emergency use authorization (EUA) after the test was validated and a notification was provided to the FDA. While this policy expedited the availability of tests, the FDA contends that the policy also led to some poorly-performing tests being offered prior to FDA review. Notably, this prior policy did not apply to at-home or point of care collection tests, which have always required FDA review.
Continue Reading HHS Again Requires FDA Premarket Review for COVID-19 Tests
On November 4, 2021, the Department of Justice (DOJ) announced the conviction of several South Florida addiction treatment facility operators following a seven-week trial. The initial indictment was filed in September 2020, charging ten defendants for their alleged conduct in committing health care fraud, wire fraud, violations of the Eliminating Kickbacks in Recovery Act (EKRA), the Anti-Kickback Statute, and money laundering. The defendants included the co-owners of two entities providing treatment and therapy for substance use disorder, several other management level individuals, a referring chiropractor, and several marketing employees.
Continue Reading DOJ Focused on Toxicology Testing – EKRA and Anti-Kickback Statute Violations Abound