DOJ Announces Settlement with EHR Company to Resolve Criminal and Civil Kickback Investigations Tied to Opioid Prescribing

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

OCR Comments on Recent Ciox Case Vacating Certain Omnibus Rule Regulations and Guidance Relating to Fees for Providing Patient Records

The U.S. Department of Health and Human Services’s (HHS) Office for Civil Rights (OCR) issued an Important Notice Regarding Individuals’ Right of Access to Health Records through its email list serve on January 29, 2020.  In the Notice, OCR addressed the recent memorandum Opinion issued in Ciox Health v. Azar, et al, No. 18-cv-00040 (D.D.C. January 23, 2020).

In that case, Ciox Health, LLC, a specialized medical records provider, had challenged certain provisions of the 2013 Omnibus Rule, including provisions pertaining to what can be charged for delivering records containing protected health information (PHI). One cited issue was whether the limitations on fees for these services applied only to requests for PHI that are made by the patient, for use by the patient (the Patient Rate), or whether the limitations also applied to PHI to be delivered to third parties. Continue Reading

DOJ and FTC Announce Draft Vertical Merger Guidelines

On January 10, 2020, The Department of Justice (DOJ) and Federal Trade Commission (FTC) announced new draft vertical merger guidelines for public comment. Once finalized, the draft guidelines will replace the DOJ’s 1984 Non-Horizontal Merger Guidelines and describe how the FTC and the DOJ will analyze and enforce vertical mergers for compliance with the antitrust laws. Vertical mergers combine two or more companies operating at different levels of the same supply chain, e.g., a combination between a hospital and independent physician group, or a health system and a skilled nursing facility. The draft guidelines adopt common concepts from the Horizontal Merger Guidelines, such as the definition of a “market,” the framework for analyzing the sale of a failing business or its assets, and the purchase of partial ownership interests. Notably, and to the disappointment of many within the health care community, the draft guidelines provide little guidance on vertical mergers specific to the health care industry. Additionally, two FTC Commissioners abstained from voting on the draft guidelines and issued statements outlining their concerns that the guidelines are too lenient toward vertical mergers.

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Bipartisan Bill for Federal Regulation of CBD in Foods and Dietary Supplements

bipartisan bill was introduced in the U.S. House of Representatives on January 13, 2020, that (1) would allow hemp-derived cannabidiol (CBD) to be regulated as a dietary supplement, if all other applicable requirements for a dietary supplement are met, and (2) would not prohibit CBD from being included in foods that are introduced into interstate commerce. The bill was filed by the Chairman of the House Agricultural Committee, Representative Collin Peterson (D-MN), and co-sponsored by Representatives Thomas Massie (R-KY), James Comer (R-KY) and Chellie Pingree (D-ME). Continue Reading

DOJ Reaches Settlement with Patient Assistance Foundation Resolving Allegations of FCA Violations

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.

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Connecticut Governor Lamont Issues Executive Orders Aiming to Contain Health Care Cost Growth and Improve Transparency

On January 22, 2020, Connecticut Governor Ned Lamont issued two health care-related executive orders, Executive Order No. 5 and Executive Order No. 6, (the Executive Orders) to address the increasing cost of health care in Connecticut. The Executive Orders build upon the state’s Office of Health Strategy’s (OHS) obligation to create a health care cost-containment strategy for Connecticut.

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OCR Announces Second $85,000 Settlement for Alleged Violations of the Individual Right of Access under HIPAA

On December 12, 2019, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) announced its second “HIPAA Right of Access Initiative” settlement of alleged HIPAA violations.

The HIPAA Right of Access Initiative is a recent effort by OCR to monitor compliance with HIPAA requirements addressing patient rights to prompt access to medical records, in a readily producible format, without being subject to excessive fees. OCR announced its first settlement under the Right of Access Initiative in September 2019 (see our analysis of that settlement here), and this second settlement indicates a continued focus by OCR on HIPAA compliance by providers when responding to patient requests for records. Continue Reading

CMS to Repay Hospitals Millions After Court Finds Reduction in Rates Improper

On December 12, 2019, the Centers for Medicare and Medicaid Services (CMS) announced that it will automatically reprocess claims which had been reimbursed at a reduced rate in 2019 under the site-neutral payment policy and pay hospitals monies that were withheld due to the policy.

In November 2018, CMS promulgated a Final Outpatient Prospective Payment System (OPPS) Rule and implemented its site-neutral payment policy, which cut Medicare reimbursement rates for outpatient hospital services provided at certain off-campus, provider-based departments (PBDs) to the lower Physician Fee Schedule (PFS) rate for the clinic visit services – a 60 percent reduction from the OPPS reimbursement rate for the same service. CMS planned to phase in application of this payment reduction over two years. The American Hospital Association, Association of American Medical Colleges, and nearly 40 hospitals challenged the policy, arguing that the Medicare Act did not allow CMS to cut the rates. CMS believed it could develop a method to set payment rates for a particular service that is causing “an unnecessary increase in cost and volume without regard to budget neutrality.” Continue Reading

DOJ Announces $26.67 Million Settlement with Laboratory to Resolve FCA Allegations

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 Physician Self-Referral (Stark) Law Settlement in Excess of $46 Million with California Health System and Surgical Group

On November 15, 2019, the Department of Justice (DOJ) announced it had reached a settlement with Sutter Health (Sutter) and Sacramento Cardiovascular Surgeons Medical Group Inc. (Sac Cardio) to resolve alleged violations of the Physician Self-Referral Law (PSR Law), commonly known as the Stark Law. Sutter is a California-based health services provider; Sac Cardio is a Sacramento-based practice group of three cardiovascular surgeons. The total settlement in excess of $46 million includes $30.5 million from Sutter to resolve allegations of an improper financial relationship specific to compensation arrangements with Sac Cardio. Sac Cardio has agreed to pay $506,000 to resolve allegations of duplicative billing associated with one of these compensation arrangements. Separately, the settlement includes another $15,117,516 from Sutter to resolve self-disclosed conduct principally concerning the PSR Law. Continue Reading

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