September 12, 2019
On September 10, 2019, the Office of Inspector General of the Department of Health and Human Services (“OIG”) published Advisory Opinion 19-04. In this favorable opinion, OIG approved a technology company’s proposal to make its online healthcare directory search results visible to federal healthcare beneficiaries in locations where the company charges the healthcare professionals a per-click or per-booking fee to be included in the directory. It also approved the company’s proposal to make sponsored advertisements that appear on its online healthcare directory and on third-party websites visible to federal healthcare beneficiaries.
June 6, 2019
On February 27, 2019, Tennessee-based holding company Vanguard Healthcare, LLC (“Vanguard”), agreed to pay over $18 million to settle a False Claims Act (“FCA”) action brought by the United States and the state of Tennessee for “grossly substandard nursing home services.” The settlement stems from allegations that five Vanguard-operated facilities failed to do the following: (1) administer medications as prescribed, (2) provide standard infection control resulting in urinary tract and wound infections, (3) attend to the basic nutrition and hygiene requirements of residents, (4) take prophylactic measures to prevent pressure ulcers, and (5) use physical restraints only when necessary. The FCA makes it illegal for anyone to submit claims (or cause claims to be submitted) for reimbursement to Medicare or Medicaid that are known to be false or based on false information. This settlement also resolves allegations that the Director of Operations, CEO, and several Vanguard companies caused false and/or fraudulent claims to be submitted. Both the CEO and Director of Operations agreed to pay $250,000, and Vanguard will enter into a chain-wide corporate integrity agreement. The $18 million settlement is the largest “worthless services” settlement to date in Tennessee.
March 4, 2019
The Office of Inspector General (“OIG”) for the Department of Health and Human Services recently issued an Advisory Opinion that provides insight into how the agency evaluates arrangements that deal with the integration of technology, medicine, and patient monitoring under the federal Anti-Kickback Statute (“AKS”). In Advisory Opinion No. 19-02, OIG evaluated whether a pharmaceutical manufacturer could temporarily loan a limited-functionality smartphone to financially needy patients enrolled in federal health care programs. OIG concluded that the proposed arrangement could violate federal health care fraud laws but OIG would not impose civil monetary penalties or administrative sanctions in light of the purpose of the arrangement and certain safeguards in place. This Advisory Opinion related to the promotion of remote patient monitoring and is useful to telehealth providers and other pharmaceutical manufacturers to evaluate how OIG might analyze similar arrangements.
November 19, 2018
A dental practice and related dental management company have become the first two entities to make their way on to the newly created “High Risk – Heightened Scrutiny” list from the Office of Inspector General for the United States Department of Health and Human Services (the “OIG”).
November 15, 2018
On November 1, 2018, the Office of the Inspector General (“OIG”) for the U.S. Department of Health and Human Services (“HHS”) published an audit report finding that the U.S. Food and Drug Administration’s (“FDA”) policies and procedures were “deficient for addressing medical device cybersecurity compromises.” (A copy of OIG’s complete report is available here and Report in Brief is available here.) Specifically, the OIG found that FDA’s policies and procedures were “insufficient for handling postmarket medical device cybersecurity events” and that FDA had not adequately tested its ability to respond to emergencies resulting from cybersecurity events in medical devices. Although the OIG report “did not identify evidence that FDA mismanaged or responded untimely to a reported medical device cybersecurity event,” it noted that “existing policies and procedures did not include effective practices for responding to these events.”
August 24, 2018
On Monday, August 12, 2018, the U.S. Department of Justice (“DOJ”) announced a new addition to its regional Medicare Fraud Strike Forces: a Newark/Philadelphia Regional Medicare Strike Force that will target both healthcare fraud and opioid overprescription. The newly-formed Newark/Philadelphia Strike Force joins nine existing regional Medicare Strike Forces, all of which are focused in geographical areas of high healthcare fraud risk: Miami, Florida; Los Angeles, California; Detroit, Michigan; Southern Texas; Southern Louisiana; Brooklyn, New York; Tampa, Florida; Chicago, Illinois; and Dallas, Texas. The Newark/Philadelphia Strike Force will be supported by the resources of several federal agencies, including the Health Care Fraud Unit of the Justice Department’s Criminal Division’s Fraud Section, the U.S. Attorney’s Offices for the District of New Jersey and the Eastern District of Pennsylvania, the FBI, U.S. Department of Health and Human Services Office of the Inspector General (“OIG”), and the U.S. Drug Enforcement Administration.
August 9, 2018
The Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services issued Advisory Opinion No. 18-03 in support of an arrangement where a federally qualified health center look-alike (the “Provider”) would donate free information technology-related equipment and services to a county health clinic (the “County Clinic”) to facilitate telemedicine encounters with the County Clinic’s patients (the “Proposed Arrangement”). The OIG concluded that although the Proposed Arrangement could potentially generate prohibited remuneration under the federal Anti-Kickback Statute (“AKS”) and Civil Monetary Penalties Law (“CMPL”) with the requisite intent to induce or reward referrals of federal health care programs, the OIG would exercise its discretion and not sanction the Provider or the County Clinic (collectively the “Requestors”).
June 29, 2018
On June 25, 2018, President Trump signed into law the Whistleblower Protection Coordination Act (the “Act”), permanently reinstating the Whistleblower Ombudsman Program, which was created in 2012 to encourage employees of federal government administrative agencies to report wrongdoing but expired on November 27, 2017 due to a five-year sunset clause.
May 3, 2018
The U.S. Department of Health and Human Services’ Office of Inspector General (OIG) recently released a report revealing that during OIG’s 2014 and 2015 audits of telehealth claims, more than half of the professional telehealth claims paid by the Medicare program did not have matching originating-site facility claims.
April 17, 2018
The Health Care Compliance Association (HCCA) kicked off its 22nd Annual Compliance Institute on Monday, April 16, 2018. During the opening remarks, Inspector General Daniel Levinson, of the Department of Health and Human Services (HHS) Office of Inspector General Office (OIG), announced the rollout of a new public resource to assist companies in ensuring compliance with Federal health care laws. The Compliance Resource Portal on the OIG’s website features: