Hospitals & Health Systems

Last week, Mintz Levin’s Health Care Enforcement Defense Group published a new Qui Tam Update, which analyzes 46 health care-related False Claims Act qui tam cases unsealed in February and March 2018 and the trends they reflect:

  • Long delays in unsealing remain common. While one case was unsealed after 61 days (just one day over the 60-day period specified by statute), the average time under seal for these cases was 851 days (i.e., approximately 2 years, 4 months). The oldest case was under seal for just over 6 years.
  • 17 of the 46 cases were dismissed in their entirety. The remaining 29 cases were still active.
  • Former employees were again the most common type of relator, accounting for 23 of the 46 cases at issue. Current employees and business partners were also among relators.
    • Notably, patients joined the relator ranks in two of the cases we reviewed.
  • These cases were filed in 38 different courts. Jurisdictions with the most unsealed cases were:
    • Middle District of Florida (Jacksonville, Orlando, and Tampa) with six;
    • Northern District of Ohio (Cleveland) with three; and
    • District of Kansas, the Eastern District of Tennessee (Chattanooga and Knoxville), the Northern District of Illinois (Chicago), and the Southern District of Florida (Miami, Fort Lauderdale, and West Palm Beach) with two each.
  • Home health and hospice providers, as well as hospitals and hospital systems, were the most common type of defendant in the cases we reviewed (with 7 cases filed against home health and hospice providers and 7 cases filed against hospitals and hospital systems). Five cases were brought against pharmaceutical and biotech firms; three cases were filed against physicians and physician practices; and three case were filed against health insurers.

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

Clinical laboratories and hospitals should note the potential changes to the Protecting Access to Medicare Act of 2014 (“PAMA”) reporting requirements tucked into the 1,400 page Physician Fee Schedule Proposed Rule (the “Proposed Rule”) released by CMS earlier this month. If finalized, these proposals would likely expand the number of laboratories, including hospital laboratories, subject to PAMA’s reporting requirements and may ultimately impact the rates paid under the Medicare Clinical Laboratory Fee Schedule (“MCLFS”).

As discussed in a previous post, PAMA made sweeping changes to the rate-setting process under the MCLFS. PAMA and its implementing regulations require “applicable laboratories” to report the private payor rates they receive for laboratory tests during specific data collection periods, and those rates then determine the rates paid under the MCLFS. Continue Reading Potential Changes to PAMA Reporting in Medicare Physician Fee Schedule Rule

It seems like every week, there are multiple new developments in the 340B program.  While it has just been a few weeks since my last 340B blog post, since that time we have had another Senate hearing, a new GAO Report, a new House hearing, and introduction of more than a dozen new bills in Congress.  But why, despite all these developments, does it feels like little has actually changed in the 340B world since January?  Continue Reading July 2018: Where Are We Now With 340B?

Congress is in session this week with six important health care hearings, including hearings on Medicare fraud, mental health, and Stark reform. Meanwhile, the Administration continues to put forth new proposed rules and guidance that will impact many stakeholders between now and the end of the year. We cover this and more in this week’s health care preview, which you can find by clicking here.

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

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

Late last month, Senators Grassley (R-IA), Brown (D-OH), and Blumenthal (D-CT) introduced the Fighting the Opioid Epidemic with Sunshine Act, a bill that would expand Physician Payment Sunshine Act reporting requirements to cover payments and other transfers of value made to advance practice nurses and physician assistants. As indicated in Senator Grassley’s announcement of the bill, the Senators are tying the expansion of the Sunshine Act to addressing the opioid epidemic.  Applicable manufacturers who are required to report Sunshine Act data through the Open Payments system should follow this bill.  As Congress continues to consider opioid issues, this bill could be included in a broader package of legislation. Continue Reading New Bill Would Expand the Sunshine Act to Cover Physician Assistants and Advance Practice Nurses

On Wednesday May 9th, I was floored when the Administration released the Spring 2018 Unified Agenda of Regulatory and Deregulatory Actions, which contained this nugget: by December 2018, HRSA will publish its 340B Omnibus Guidance. Readers of our blog know that, as we predicted, this so-called Mega-Guidance was withdrawn in January 2017 without ever seeing the light of day. Within a day, the Unified Agenda was reposted with references to the so-called 340B Mega-Guidance removed, and HRSA acknowledged that its inclusion in the Unified Agenda was an error. The 340B Guidance remains shelved.  Continue Reading Last Week in 340B: the Revival [not] of the 340B Mega-Guidance, Another Senate Hearing, and the Trump Blueprint to Lower Drug Prices

Earlier this week, our colleague Don Davis addressed the increasing amount of disability discrimination litigation against health care entities on the Employment Matters Blog. In the blog post, Don provides an overview of the Americans with Disabilities Act (“ADA), describes employment disability discrimination litigation and enforcement trends in the health care industry, and highlights the recent spike in accessibility-related litigation (including issues related to both facility accessibility and website accessibility).

The full post is available here.

On Tuesday, May 8th, the House held three hearings related to combating the opioid epidemic. The first hearing came out of the Energy and Commerce (E&C) Subcommittee on Oversight and Investigations, which examined opioid distribution and diversion by the pharmaceutical industry. The second hearing came out of the E&C Subcommittee on Health, which examined the current statutory restrictiveness on the medical profession’s ability to coordinate substance use disorder (SUD) treatment due to prohibitions on certain patient information disclosure. The third hearing came out of the House Judiciary Committee and examined best practices in international and domestic enforcement on drug traffickers in curbing the supply of opioids across the U.S. Continue Reading Congress Holds Hearings and Proposes Legislation to Combat Vexing Opioid Crisis