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

The July 2018 cyber security newsletter issued by the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) reminds health care providers and their business associates of the importance of properly disposing and destroying electronic devices and/or media that are no longer needed or that will be repurposed.  The HIPAA Security Rule requires covered entities and business associates to have policies and procedures in place that govern that proper disposal and re-use of hardware and electronic media that contains electronic protected health information (“ePHI”).

Continue Reading OCR Warns Providers About Securely Disposing Electronic Devices

At the end of July, CMS approved two Section 1332 State Innovation Waivers submitted by Wisconsin and Maine for the purpose of establishing state reinsurance programs. There has been a flurry of 1332 waiver activity recently as states have sought to stabilize their individual insurance markets through reinsurance programs. Currently, Maryland and New Jersey have pending reinsurance applications before CMS. For more on the Wisconsin, Maine, and Maryland waivers, click here.

New Jersey’s request, which was submitted on July 2nd, 2018, is summarized below. Continue Reading New Jersey’s Pending 1332 Reinsurance Waiver

On Wednesday, August 8, CMS filed a proposed rule clearing the way for the federal government to continue making payments under the ACA’s risk adjustment program for the benefit year 2018.  The 2018 proposed rule is unsurprising.  It essentially mirrors the final rule CMS issued two weeks ago for benefit year 2017, including the same technical fix to the risk adjustment methodology meant to satisfy a decision handed down in February by a federal district court judge in New Mexico, who had ruled that the use of certain risk management formulas in the program was arbitrary and capricious.  Both the 2017 final rule (which will presumably allow CMS to make billions of dollars in risk adjustment payments to plans this fall for benefit year 2017) and the 2018 proposed rule (which is designed to allow payments for benefit year 2018, to be paid out during the fall of 2018) will still need to be approved by the district court before any risk adjustment payments can be made, meaning the future structure of the risk adjustment program is far from set in stone.  The New Mexico CO-OP which had challenged the risk adjustment methodology in the first place made clear in a filing on August 1 that it will continue to fight the risk adjustment methodology.  However, CMS’s decision to continue administering the risk adjustment program is noteworthy because it represents a stark reversal from the agency’s announcement in early June that the federal government would freeze the program in response to the district court ruling. Continue Reading CMS, In a Reversal, Announces Plans to Continue Funding Risk Adjustment Payments

Last week, the Department of Health and Human Services – Office of Inspector General (“OIG”) released a portfolio report identifying multiple vulnerabilities in the Medicare Hospice Program (the “Hospice Portfolio Report”), including concerns around billing, federal oversight, and quality of care. The OIG made 16 recommendations to CMS to strengthen the hospice program; CMS only concurred with 6 of the recommendations.

Notwithstanding CMS’ non-concurrence to the majority of the OIG’s recommendations, these findings may preview increased enforcement actions in the hospice space. In recent years, the OIG has released two other portfolio reports: one on vulnerabilities in Medicaid personal care services (“PCS”) and a second on the Medicare Part D program. Following the release of each of these reports, the number of reported investigations and prosecutions in the affected spaces surged. For example, since the OIG’s release of its report on PCS in 2012, the OIG has opened more than 200 federal criminal investigations involving fraud and patient harm by PCS providers; state investigations similarly increased.

This post outlines the OIG’s findings and recommendations related to hospice program vulnerabilities, as well as what these findings and recommendations may mean for hospice providers. Continue Reading The OIG Identifies “Significant Vulnerabilities” in the Medicare Hospice Program: What This Might Mean for Hospice Providers?

States are increasingly looking for ways to improve stability in their individual insurance marketplaces. One way is through reinsurance programs – systems in which multiple insurance companies share risk by purchasing insurance policies from another party to limit the total loss the original insurer would experience in case of unusually high claims. To date, Alaska, Minnesota, and Oregon have established state reinsurance programs through Section 1332 State Innovation Waivers, according to the Kaiser Family Foundation. More are on the way.

Recently, there has been significant activity on using Section 1332 waivers to implement reinsurance programs. On July 29, 2018, CMS approved Wisconsin’s 1332 waiver request to implement a reinsurance program for years 2019 through 2023. On July 30, Maine’s waiver request to reinstate its reinsurance waiver was approved. Maryland and New Jersey also have pending reinsurance applications before CMS (Maryland being the most recent state to submit an application). Continue Reading Recent 1332 Waiver and Reinsurance Activity

The first statistic comes from a recently published study by the Ponemon Institute, with sponsorship from IBM Security, entitled “2018 Cost of a Data Breach Study: Global Overview.”  Ponemon’s study found that heavily regulated organizations, most notably the health care industry, face breach costs that are substantially higher than their peers. The study found that the per capita cost of a data breach in the health care industry is $408–nearly double that of the financial industry, which claims the second spot on the list. The chart below makes the health care industry’s outlier status crystal clear:  Continue Reading These Statistics Keep Health Care Execs Up At Night

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

This week, the Senate is in session while the House is out on its August recess. The Senate could move the ball on opioids, but it is more likely that it focuses on nominations. Meanwhile, the Administration remains hard at work on the regulatory side, with the Short-Term, Limited Duration Insurance regulation expected in the near future. We cover this and more in this week’s preview, which you can find here.

In May, the Trump Administration announced its Blueprint to Lower Drug Prices and HHS Secretary Azar issued a Request for Information seeking comments from interested parties “to help shape future policy development and agency action” related to drug pricing issues.  Since that time, many industry commentators questioned whether any of the vague goals in the Blueprint would or could be turned into concrete action.

This month, the Trump Administration has attempted to answer that question through a variety of HHS and FDA initiatives.  Here’s what you need to know about drug pricing developments so far in July. Continue Reading Significant Drug Pricing Developments in July – Here’s What You Need To Know