Cybersecurity, Inside Jobs, Outside Jobs, and HIPAA

According to a February 12, 2019 Press Release from Protenus, a developer of analytics for patient privacy monitoring and compliance, 15,085,302 patient records were breached in 2018 – a startling number made even more startling by the fact that the number of breached patient records in 2018 is three times greater than the number of records breached in 2017.

As evidenced by the Protenus data and information reported by the U.S. Department of Health and Human Services (“DHHS”), Office of Civil Rights (“OCR”), a growing number of these breaches relate to third-party hacking, ransomware, and related malware incidents (collectively, “Hacking/IT Incidents”). As such, the OCR data shines a bright light on the obvious difficulties that healthcare entities (“Covered Entities”) covered by the security and confidentiality requirements applicable to protected health information (“PHI”) under the Health Insurance Portability and Accountability Act of 1996 and 45 CFR Parts 160 and 164, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”) (collectively referred to hereinafter as “HIPAA”).

The following examines representative HIPAA settlements and rulings from 2018, and considers the 2018 breach statistics and the growing security risk associated with Hacking/IT Incidents. Continue Reading

For Tax-Exempt Employers: 403(b) Retirement Plan Compliance Opportunity

Tax-exempt employers have a special opportunity to fix compliance concerns with their 403(b) retirement plans. They have through March 31, 2020 – the “Remedial Amendment Period” (RAP) – to retroactively self-correct compliance issues with their 403(b) plan documents, without going through the IRS’ more costly and time-consuming process that would normally be required. An overview of this opportunity is below. Continue Reading

OIG Advisory Opinion No. 19-03: The OIG Puts the Healthcare Benefits of Free In-Home Care and the Risks of Patient Steering in the Balance

OIG Advisory Opinion No. 19-03

On March 6, 2019, the Department of Health & Human Services, Office of the Inspector General (“OIG”) published a new advisory opinion, No. 19-03 (the “AO”), addressing a proposed arrangement to provide free post-discharge support to patients. The OIG determined that it would not impose sanctions under either the Civil Monetary Penalties law (“CMPL”) or the federal health care program Anti-Kickback Statute (“AKS”), offering some comfort to providers who seek to implement – or who have already implemented – similar programs. However, the OIG’s assertion that the proposed program would not fall within the “promotes access to care” exception to the CMPL indicates a potentially worrisome and narrow interpretation of a facially broad statutory exception. Continue Reading

HIMSS19 Brings Together Thought Leaders on IOT and Telehealth

In our February 13, 2019 blog post, “HIMSS19 Kicks-Off Addressing Leading Topics in Healthcare Information Technology,” we reported on the buzz that emerged from the first two days of the Healthcare Information and Management Systems Society’s (HIMSS) annual global conference that commenced on February 11, 2019. Now that the conference has concluded, it is time to discuss the key takeaways and lessons learned from the conference’s last few days regarding the application of the Internet of Things (IOT) to healthcare. Continue Reading

HIMSS19 Kicks-Off Addressing Leading Topics in Healthcare Information Technology

Healthcare Information and Management Systems Society (HIMSS) kicked-off its annual global conference this week in Orlando, Florida, addressing leading topics in healthcare information technology. Over 45,000 healthcare and information technology professionals and 1,300+ vendors are expected to attend the week long event.   Continue Reading

HHS Proposes Rule to Eliminate Safe Harbor for PBM Drug Rebates

On February 6, 2019, the Office of the Inspector General of the U.S. Department of Health and Human Services (the “OIG”) published in the Federal Register a proposed rule (the “Proposed Rule”) that, if made final in its current form, would (i) amend the Anti-kickback Statute (“AKS”) Discount Safe Harbor to explicitly exclude discounts relating to price reductions or other remuneration offered by a pharmaceutical manufacturer to a Medicare Part D plan sponsor (“Plan Sponsor”), a Medicaid managed care organization (“MCO”), and/or a pharmacy benefit manager (“PBM”) under contract with such a sponsor or organization; and (ii) add two new safe harbors: a “Discounts Offered at the Point-of-Sale” safe harbor (“Point of Sale Safe Harbor”) and a PBM Fee Arrangement Safe Harbor (“PBM Safe Harbor”). Continue Reading

How Blockchain Technology Brings Value to Healthcare

Blockchain applications for healthcare have garnered significant attention recently. For example, as we recently blogged, five major healthcare companies – Humana, MultiPlan, Optum, Quest Diagnostics, and UnitedHealthcare – formed the Synaptic Health Alliance (the “Alliance”) to explore how blockchain technology could resolve current healthcare issues. Continue Reading

Government Puts Electronic Health Records Companies “on Notice” of Vigorous False Claims Act Enforcement

Federal prosecutors announced yesterday the Government’s settlement with electronic health records (“EHR”) vendor Greenway Health, LLC (“Greenway”) of False Claims Act (“FCA”) allegations for a payment of $57.25 million and Greenway’s acceptance of a Corporate Integrity Agreement (“CIA”). The Government’s FCA complaint was filed by the U.S. Attorney’s Office for the District of Vermont, the same office that handled the May 2017 civil settlement with EHR company eClinicalWorks for $155 million. The Greenway settlement is the second largest civil settlement in the District of Vermont’s history, topped only by the eClinicalWorks settlement. Continue Reading

Compliance Risk Alert: Opioid Warning Letters issued by the U.S. Department of Justice Target Prescribers

U.S. Attorney’s Offices (“USAOs”) across the country are issuing warning letters to physicians and other prescribers (collectively, “Prescribers”) cautioning them about their opioid prescribing practices (the “Warning Letters”). In just the last week, the USAO for the Eastern District of Wisconsin sent warning letters to over 180 prescribers identified by Drug Enforcement Administration (“DEA”) data as prescribing opioids at relatively high levels. The Food and Drug Administration and the Federal Trade Commission have also been issuing their own warning letters to opioid marketers and distributors over the past several months, evidencing a concerted effort to combat the opioid epidemic on a number of fronts through various federal enforcement and regulatory efforts. Continue Reading

Hospice Short Film End Game Up For Academy Award

Though beloved as a service, hospice can be a difficult subject for patients, families, and even caregivers. The recent short filmEnd Game (2018 NetFlix), follows a set of patients, families, and their caregivers through the difficult discussions and choices faced at end of life. It may help facilitate difficult discussions.

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