Health Law & Policy Matters

Keeping Your Business Healthy

The Second Circuit Court of Appeals recently held that a False Claims Act (FCA) relator could not evade the FCA’s first-to-file bar by filing an amended complaint after two earlier-filed FCA suits alleging similar conduct had been dismissed. United States ex rel. Wood v. Allergan, Inc., No. 17-cv-2191 (2d Cir. July 17, 2017). The FCA’s first-to-file bar prohibits a relator from bringing a “related action” when an FCA lawsuit is “pending.” In Wood, relator filed…
As a continuation of the recent drug pricing developments tied the Trump Administration’s American Patients First Blueprint, beginning January 1, 2019, Medicare Advantage plans will be able to apply step therapy for physician-administered and other Part B drugs in an effort that CMS hopes will lower drug costs and improve the quality of care for Medicare beneficiaries. In addition, Medicare Advantage plans will be able to “cross-manage” across Medicare Part B and Part D,…
Employers with workers in Massachusetts will have a lot to do between now and October 1, 2018, when reforms to Massachusetts non-compete laws go into effect.  Our colleagues Katharine Beattie and Jennifer Budoff have covered the changes (and necessary action items for employers) on Mintz’s Employment Law Matters Blog.  From health systems to technology start-ups, these changes require employers to evaluate their approach to non-competes with their employees and to ensure compliant practices in…
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…
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…
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,…
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…
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…
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.…
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…