Legal Insights and Perspectives for the Healthcare Industry

We invite you to join us on Wednesday, October 30, for Part 1 of our two-part Fast Break: Regulatory Sprint webinar. In a recent Health Law Scan post, we highlighted two rules proposed by the Office of the Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) that seek to alter the landscape of healthcare program integrity and fraud and abuse regulation, as part of what the US Department of Health and Human Services calls the “Regulatory Sprint to Coordinated Care Initiative.” In Part 1 of this Fast Break, Donna Clark, Albert Shay, and Jacob Harper will discuss the CMS’s proposed rule on Stark Law changes. Stay tuned for Part 2 when we discuss the OIG’s proposed rule on Anti-Kickback Statute and Civil Money Penalty changes.

Register for the webinar now.

Our global employment and immigration team recently issued alerts on decisions that affect the healthcare industry. The team discussed a new presidential proclamation that effectively makes foreign nationals inadmissible to the United States unless they have “approved” health insurance coverage, and noted that a trio of district courts have halted federal enforcement of the public charge rule. The team had previously summarized the public charge rule, which will not take effect so long as the district court lawsuits are pending.

Read New DHS ‘Public Charge’ Rule Could Have Employment-Based Implications >

Read USCIS to Implement New Public Charge Rule; White House Introduces Health Insurance Requirement for Immigrant Visa Applicants >

Read Federal Courts Halt New Public Charge Rule >

The US Food and Drug Administration (FDA) recently issued new draft guidance on clinical decision support (CDS) software that revamps the agency’s interpretation of the 21st Century Cures Act and proposes new policies of enforcement discretion for some categories of CDS software. In a recent LawFlash, Morgan Lewis partner Michele Buenafe details key takeaways from the revised guidance, which is a significant departure from the 2017 draft.

Read the LawFlash >

Traditionally a month of beginnings and endings, September is when we transition from the idle warmth of long summer days to the heightened activity of a chilled and busy autumn. For Health Law Scan, September was notable for our analysis of the US Court of Appeals for the Eleventh Circuit’s decision in United States v. Aseracare, which found that mere differences of clinical opinion cannot be fraud under the False Claims Act.

We invite you to join us on Thursday, October 17, for an overview discussion about federal rulemaking, including procedural and de facto changes under the current administration. In this A–Z of Federal Rulemaking webinarSusan Harthill, Jonathan Snare, and Timothy Lynch will discuss the impact of participating in federal rulemaking, how to get involved, the roles of the Office of Management and Budget and Office of Information and Regulatory Affairs, and more.

Register for the webinar now >

Highlighting the US Department of Health and Human Services’ (HHS) efforts to transform the US healthcare system to a value-based model, the Office of the Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) have issued two proposed rules that seek to alter the landscape of healthcare program integrity and fraud and abuse regulation, as part of what HHS calls the “Regulatory Sprint to Coordinated Care Initiative.”

The HHS Regulatory Sprint identifies four lanes to better coordinate care:

  • Improving a patient’s ability to understand his/her treatment plans and be empowered to make decisions
  • Increasing providers’ alignment on end-to-end treatment
  • Providing incentives for providers to coordinate and collaborate care with their patients
  • Encouraging information sharing among providers, facilities, and other stakeholders in a manner that facilitates efficient care while preserving and protecting patient access to data

New York’s Stop Hacks and Improve Electronic Data Security Act, or SHIELD Act, which makes significant changes to the state’s data breach notification requirements, impacts healthcare organizations that hold computerized data with private information from New York residents. In this LawFlash, our privacy and cybersecurity team analyzes the law’s expanded definition of “private information” and offers key business takeaways for assessing compliance with the SHIELD Act, which becomes effective October 23, 2019.

Read the LawFlash >>

The Nuclear Regulatory Commission (NRC), which regulates the medical use of radioactive materials, relies on the Advisory Committee on the Medical Use of Isotopes (ACMUI) to identify and evaluate the common causes of medical events that are reported by licensees. In an Up & Atom blog post, Morgan Lewis partner Lewis Csedrik and associate Roland Backhaus detail the ACMUI’s most recent review of reported medical events and discuss the NRC’s Information Notice with recommendations to prevent their reoccurrence.

Read the Blog Post  >>

It’s October 1, and that means this month is the deadline for the US Drug Enforcement Agency (DEA) to issue its final rules on special registration for telemedicine. The SUPPORT Act, signed into law on October 24, 2018, gave the DEA one year to promulgate regulations specifying the circumstances under which special registration may be obtained and the procedure for doing so. When finalized, special registration should give telehealth providers significantly more flexibility to prescribe controlled substances without first performing in-person exams.

Our prior post discussed three potential enhancements to cyber-related liability insurance policies designed to maximize their potential responsiveness to actions initiated by consumers or the state attorney general under the California Consumer Privacy Act (CCPA). Today, we offer four additional suggested coverage enhancements for consideration in advance of the CCPA’s January 20, 2020, effective date: