Privacy and security compliance obligations for health care companies remain hot topics this spring. Health care companies must now contend with data breach laws in all 50 states as well as keeping on top of federal HIPAA developments.

New Colorado Data Breach Law

Our Privacy and Security colleagues recently blogged about a new Colorado law that imposes strict requirements on entities that maintain, own, or license personal identifying information of Colorado residents. The law broadly defines “personal identifying information” as a Social Security number; a person identification number; a password or passcode; a driver’s license or identification card number; a passport number; biometric data; an employer, student, or military identification number; or a financial transaction device. In addition, the law requires entities to report breaches of such data within 30 days of discovery.

Continue Reading Privacy and Security Round-up – Colorado Data Breach Law, Guidance from OCR

A lot has happened since we last addressed new biosimilar developments in January 2018. In the intervening months, there have been many significant developments related to FDA’s implementation of an efficient regulatory program for biosimilar products and the abbreviated BLA (aBLA) review process. Today we’re going to recap some of what has transpired over the past 5 months in the biosimilars space in an attempt to get our readers caught up. Continue Reading Biosimilars in the Limelight – A Lot Has Happened Since January 2018

It has been a few weeks since the publication of the Trump Administration’s Blueprint to Lower Drug Prices, and Secretary Azar’s  Request for Information (RFI) on the Blueprint.  We previously posted about the Blueprint’s focus on the 340B Drug Discount Program.

Many have speculated about the possible changes in store for Medicare under the Blueprint, especially the potential changes to Medicare Parts B and D.  But what about Medicaid?  Unlike Medicare, the federal government does not have exclusive authority to impose operational changes in Medicaid, because of the role of the individual states (and DC) in administering their own Medicaid Programs.  What do the Blueprint and RFI say about Medicaid, and what are the potential implications? Continue Reading A Deeper Dive: What the Trump Administration Blueprint to Lower Drug Prices Might Mean for Medicaid

Welcome to the third week of this four week stretch. This week, the House will continue to vote on a number of proposals to address the opioid crisis. Last week the House passed over 30 bills on opioids, most of which were non-controversial and reached bipartisan support. However, the bills considered this week are expected to have spending tied to them and could therefore be more controversial.  We cover this and more in this week’s health care preview, which you can find here.

On Thursday June 14, 2018, the US Court of Appeals for the Federal Circuit ruled against two health plans seeking risk corridors payments from the federal government. A more detailed background on the program and pending litigation is available in my prior post hereContinue Reading Appeals Court Rejects Insurers Risk Corridors Claims

Earlier this week, I moderated a panel discussion at an event hosted by the New York chapter of the Health Information and Management Systems Society (HIMSS). The panel was comprised of private sector health information technology and security experts and was tasked with discussing challenges related to the interoperability and security of health information systems. I started off by asking the panelists how these challenges have evolved over the years, anticipating that the conversation would soon turn to the challenges faced by newer technologies such as cloud computing and artificial intelligence. But it was the panelists’ opinion that many in the health care space continue to struggle with the basics, including basic HIPAA compliance. Continue Reading HIPAA Tips from the Trenches

Many provisions of the Affordable Care Act (“ACA”) have been the subject of litigation over the last decade, with several high-profile Supreme Court cases including: NFIB v. Sebelius, King v. Burwell, and Burwell v. Hobby Lobby. One of the more overlooked topics of litigation has been the ACA’s “Risk Corridors” program. This has recently changed because a decision is anticipated in the consolidated appeal of two important risk corridors cases currently pending in a federal appeals court. Continue Reading Decision Expected Soon in Ongoing Risk Corridors Litigation

Last week, Mintz Levin’s Health Care Enforcement Defense Group published a new Qui Tam Update, which analyzes 60 health care-related False Claims Act qui tam cases unsealed in December 2017 and January 2018 and the trends they reflect:

  • The government intervened in 14% of those unsealed cases (a figure that is consistent with the longer-term trends we have seen over the prior twelve months).
  • Of the 60 unsealed cases, only 28 were being litigated (at least initially). The remaining 32 cases were docketed as closed or dismissed.
  • The 60 unsealed cases were filed in 38 different courts. Jurisdictions with the most unsealed cases included:
    • The Central District of California (which includes Los Angeles) with six cases;
    • The Middle District of Florida (which includes Jacksonville, Orlando, and Tampa) with 4 cases; and
    • The District of Connecticut and Eastern District of Louisiana (New Orleans), each with 3 cases.
  • The most frequently targeted types of defendants included:
    • Pharmaceutical companies, hospitals, and healthcare systems, with each accounting for 9 of the 60 unsealed cases.
    • Physicians and physician group practices, which were targeted in 7 cases.
    • Home health and hospice providers, which were the subject of 6 cases.
    • Outpatient clinics, which were defendants in 5 cases.
  • Former employees were again the most frequent relator type, accounting for 23 of the 60 unsealed cases. Expert witnesses brought 7 cases and current employees brought 2 cases.
  • Only one of the cases was unsealed within the 60-day period specified by statute. That case was under seal for 55 days.
  • The longest time a case was under seal was almost eight-and-a-half years. Average time under seal for this cohort was 700 days, though half of these cases were unsealed in 16 months or less, and 23 of these 60 cases were unsealed in less than a year.

Continue Reading Mintz Levin’s Health Care Enforcement Defense Group Publishes New Qui Tam Update

This week the Senate Finance Committee will mark up its opioid package. Additionally, the HELP Committee will hear from Secretary Azar on the Administration’s effort to lower prescription drug prices. For our complete review and what else to watch for this week, click here.