Legal Insights and Perspectives for the Healthcare Industry

In an action especially significant to hospice providers but also other healthcare providers regarding the determinations of medical necessity for Medicare billing purposes, the US Department of Justice (DOJ) and AseraCare have just agreed, following a mediation, to settle for $1 million the long-running False Claims Act qui tam litigation matter in which the United States had previously sought $200 million in liability.

In its press release, Aseracare said the settlement involves a single payment and will not require a corporate integrity agreement with the HHS Office of Inspector General.

Join Morgan Lewis over the next month for these programs focused on the healthcare industry:

We invite you to join us on Thursday, February 27 for our next installment of the Fast Break series. In a recent post, we highlighted staffing-related trends that arise in collective bargaining in the healthcare industry. For this month’s edition of Fast Break, we will be joined by partner Douglas Hart to discuss the recent National Labor Relations Board labor law changes and what healthcare providers should expect for 2020.

Register for the webinar now.

The Nuclear Regulatory Commission (NRC), which regulates the medical use of radioactive materials, recently updated guidance for materials licensees with respect to the administration of radioisotopes. In an Up & Atom blog post, Morgan Lewis partner Lewis Csedrik and associate Roland Backhaus address two recent NRC Information Notices on medical events involving overexposure to strontium-82/rubidium-82 generator elution and the administration of YU-90 microspheres, and discuss the NRC’s recommendations to prevent their reoccurrence.

Read the Blog Post>

The Centers for Medicare & Medicaid Services (CMS) unveiled the Healthy Adult Opportunity initiative on January 30. Morgan Lewis partner Susan Feigin Harris recently spoke with Fierce Healthcare about the CMS block grant, and specifically discussed the possibility of the program seeing a challenge in court. “It is a classic constitutional case of who gets to allocate funding and who gets to stop allocating funding and that is Congress,” she said.

Read the full Fierce Healthcare article >>

In this LawFlash, our antitrust and competition team details increased jurisdictional and filing fee thresholds under the Hart-Scott-Rodino Act announced by the Federal Trade Commission (FTC) on January 28. Healthcare entities contemplating mergers, acquisitions, or other transactions that might require premerger notification should review the new thresholds, which apply to transactions closing on or after February 27, 2020.

Read the LawFlash >>

While US healthcare institutions are poised to respond to any outbreak of the 2019 Novel Coronavirus (2019-nCoV), how should they prepare as employers for the questions and compliance challenges that arise in a public health crisis? In this LawFlash, our Labor, Employment, and Benefits team cautions that “employers must carefully balance concerns relating to employee and public safety with protecting employees from unnecessary medical inquiries, harassment, and discrimination—all while complying with immigration, leave, and medical privacy laws.”  Recommending that “[r]esponsibility should be assigned to specific individuals or teams to assess the hazard, communicate with employees and the public, and implement appropriate security measures,” they detail important information that employers should know before responding to an outbreak situation.

Read the LawFlash>

Check out our Responding to the 2019 Novel Coronavirus page for all of the latest developments.

The US Department of Justice (DOJ) Antitrust Division issued a Business Review Letter (BRL) on January 15 in response to a proposal by the American Optometric Association (AOA) and AOAExcel GPO, LLC to expand their group purchasing arrangement. The AOA includes approximately 27,000 doctors of optometry (plus optometry staff and students) who compete with one another and nonmember optometrists and ophthalmologists to provide optometric services. AOA members also compete with other retail and online stores and vertically integrated providers who offer optometric products. In an effort to help their members better compete with these online and retail stores and vertically integrated manufacturers, the parties plan to expand their group purchasing arrangement to include optometric products for resale to customers. The proposed expansion would cover optometric products including eyeglass lenses and frames and contact lenses. The DOJ, in reviewing the details of the proposal, concluded that it presently does not intend to challenge the parties’ group purchasing arrangement in light of certain competitive safeguards within the structure of the expanded arrangement.

In a month of short winter days, blustery weather, and Siberian-like temperatures, Health Law Scan upped the thermostat in January beginning with an important analysis of the Texas v. Azar decision by the US Court of Appeals for the Fifth Circuit on the constitutionality of the Affordable Care Act. We followed this with a collection of super-heated posts on the FY 2020 Appropriations Act, the DOJ’s $2.6 billion in False Claims Act (FCA) recoveries, MedPAC’s recommendations for payment reductions for hospice and home health, and foreign investment in the healthcare industry under the FIRRMA final rule. In between curling practice and drinking hot chocolate, we detailed a number of important immigration developments including the decision to lift the injunction on the Public Charge rule by the US Supreme Court, and key takeaways from the US v. AseraCare decision for FCA practitioners. As January tobogganed to an icy conclusion, we recapped a pair of Fast Break webinars addressing the Year in Review and the Allina decision, and compiled a list of our most popular blog posts of 2019. So if you happened to miss a blog post or two while searching the internet on how not to turn blue, we suggest you layer up, put another log on the fire, and catch up right here.


We hope you were able to join us for two back-to-back, action-packed Fast Break sessions in December and January.

In December, Jake Harper and Dani Elks discussed the top 10 most influential events of 2019, which included the following:

  • Landmark court decisions impacting the False Claims Act, Medicare reimbursement, and medical necessity
  • Pronouncements from the US Department of Justice and CMS on enforcement priorities
  • Major new rules impacting Stark Law, the Anti-Kickback Statute, and transparency
  • Digital health innovation