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On March 17, the Trump Administration announced expanded reimbursement for clinicians providing telehealth services for Medicare beneficiaries during the COVID-19 Public Health Emergency. The Centers for Medicare and Medicaid Services (CMS) published an announcement, a fact sheet and Frequently Asked Questions.  To further facilitate telehealth services, the Office for Civil Rights (OCR) issued a notification describing certain technologies that would be permitted to be used for telehealth without being subject to penalties under the Health Insurance Portability and Accountability Act regulations (HIPAA). In addition, the Office of Inspector General (OIG) announced it will allow healthcare providers to reduce or waive cost-sharing for telehealth visits.
Continue Reading Federal Government Significantly Expands Telehealth Reimbursement During COVID-19 Public Health Emergency

The Centers for Medicare and Medicaid Services (CMS) requested an audit by the Office of Inspector General (OIG) of Medicare Part D eligibility verification transactions (E1) transactions. The OIG recently released its report which found that the majority of the providers evaluated used E1 transactions for some inappropriate purpose other than to bill for a prescription or to determine drug coverage billing order.

What are E1 transactions and why is this information disturbing?
Continue Reading OIG Audit Finds that Majority of Part D Providers Surveyed Used E1 Transactions for Potentially Inappropriate Purposes

On January 27, 2020, the Department of Justice (DOJ) announced a $145 million settlement with Practice Fusion Inc., an electronic health records (EHR) software company that resolves parallel criminal and civil investigations involving allegations of kickbacks, false claims, and non-compliance with federal EHR program requirements. We previously discussed a preliminary settlement in this case here, and in announcing the finalizing of that settlement the DOJ has shed more light on the allegedly improper conduct at issue. According to the DOJ, this is the first criminal action ever brought against an EHR company, and the “unique” deferred prosecution agreement (DPA) imposed by the DOJ against Practice Fusion that seeks “to ensure acceptance of responsibility and transparency as to” underlying conduct may reflect a new approach to settlements with corporate health care defendants.
Continue Reading DOJ Announces Settlement with EHR Company to Resolve Criminal and Civil Kickback Investigations Tied to Opioid Prescribing

On January 21, 2020, the Department of Justice (DOJ) announced a $3 million settlement with Patient Services, Inc. (PSI) to resolve allegations of False Claims Act (FCA) violations. The DOJ alleged that PSI enabled three pharmaceutical companies to pay kickbacks to patients by funneling money to patients taking drugs manufactured by those same pharmaceutical companies. In addition to the $3 million, PSI has entered into a three-year integrity agreement with Health and Human Services’s Office of the Inspector General. The settlement involved no determination of liability.
Continue Reading DOJ Reaches Settlement with Patient Assistance Foundation Resolving Allegations of FCA Violations

On November 26, 2019, the Department of Justice (DOJ) announced a $26.67 million settlement with a laboratory testing corporation, Boston Heart Diagnostics Corporation (Boston Heart). The settlement resolves allegations of False Claims Act (FCA) violations related to alleged payments for patient referrals in violation of the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (PSR Law) – commonly known as the Stark Law – and other improper billing.
Continue Reading DOJ Announces $26.67 Million Settlement with Laboratory to Resolve FCA Allegations

On October 17, 2019, the Department of Health and Human Services (HHS) published proposed rules to update the regulatory Anti-Kickback Statute (AKS) safe-harbors and exceptions to the Physician Self-Referral (PSR) Law, known commonly as the Stark Law (AKS proposed rule available here; PSR proposed rule available here). In an earlier blog post, we described each of the proposed rules. Among the proposed changes are a new safe harbor/exception that would generally permit entities to donate certain cybersecurity technology and related services to physicians, subject to compliance with the conditions described below. In the preamble to each proposed rule, the HHS Office of Inspector General (OIG) (which published the AKS proposed rule) and the Centers for Medicare and Medicaid Services (CMS) (which published the PSR proposed rule) noted that cyber-attacks in the health care industry are on the rise and cybersecurity technology can be cost-prohibitive for some providers. Both OIG and CMS stated their hope that the proposed rules will improve overall cybersecurity in the health care industry and reduce instances of data breaches resulting from cyber-attacks.
Continue Reading HHS Proposes Changes to Permit Donation of Cybersecurity Technology

On October 9, 2019, the Department of Health and Human Services (HHS) released its long-awaited proposals (the Proposed Rules) to update regulatory exceptions and safe harbors, for the federal Physician Self-Referral Law (also known as the Stark Law), the Anti-Kickback Statute (AKS), and the beneficiary inducement Civil Monetary Penalties Law (CMP). The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to update exceptions to the Physician Self-Referral Law (the PSR Rule), and the HHS Office of Inspector General (OIG) issued a proposed rule to update the AKS safe harbors and expand exceptions to the CMP’s beneficiary inducements prohibition (the AKS Rule). The Proposed Rules are intended to reduce perceived regulatory barriers to beneficial health care arrangements, and to facilitate the implementation of new approaches to health care service delivery and coordination, including value-based care models.
Continue Reading Government Releases Proposed Rules on Physician Self-Referral Law (Stark Law), Anti-Kickback Statute and CMP Law; Significant Regulatory Changes Intended to Encourage Care Coordination and Value-Based Care

On September 6, 2019, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) issued OIG Advisory Opinion No. 19-05 (Advisory Opinion) permitting a community health center (Requestor) to purchase real estate from a limited liability company (LLC) owned and managed by an individual excluded from participation in federal health care programs (Proposed Arrangement). The OIG indicated the Proposed Arrangement would not result in the imposition of sanctions under the civil monetary penalties law because no claims for reimbursement from federal programs would be sought by the Requestor, nor would they use federal grant funds to finance the purchase.
Continue Reading HHS Issues Favorable Advisory Opinion Permitting Community Health Center to Purchase Real Estate from an Excluded Individual

On September 5, 2019, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) issued OIG Advisory Opinion 19-04 (Advisory Opinion). The Requestor asked OIG if providing an online health care provider directory (Directory) to federal health care program beneficiaries (beneficiaries) would violate the Anti-Kickback Statute (AKS) or constitute a prohibited Beneficiary Inducement. The online directory would allow beneficiaries to search and book medical appointments, and the Requestor would charge health care professionals a per-click or per-booking fee to be listed in the directory. The directory would also allow sponsored advertisements for which health care professionals would pay a per-impression or per-click fee for such advertisements. The OIG indicated that the arrangement would not violate the Beneficiary Inducement prohibitions, and although it may generate remuneration prohibited by the AKS, OIG would not impose sanctions on the Requestor because the risk for federal health care program fraud or abuse is low.
Continue Reading HHS Issues Favorable Advisory Opinion for Online Health Care Directory Charging Per-Click Fees

On June 5, 2019, the Department of Justice (DOJ) announced a global settlement with Insys Therapeutics (Insys) that preliminarily resolves criminal and civil cases against the opioid manufacturer in a number of jurisdictions. Under the terms of the settlement, Insys agreed to pay a total of $225 million – $195 million in civil remedies and $30 million in criminal restitution (comprising a $2 million fine and $28 million in forfeiture). In addition to the monetary penalties, Insys entered into a five year deferred prosecution agreement with DOJ, as well as a five year Corporate Integrity Agreement (CIA) and Conditional Exclusion Release with the Office of Inspector General (OIG). Additionally, an operating subsidiary of Insys pleaded guilty to mail fraud.
Continue Reading DOJ Enters into $225 Million Settlement with Opioid Manufacturer to Resolve Criminal and Civil Investigations