Legal Insights and Perspectives for the Healthcare Industry

The US District Court for the District of Oregon on November 2 issued a temporary restraining order (TRO) to block the new health insurance requirement for immigrant visa applicants from taking effect on November 3, 2019. As discussed in an earlier alert, the White House issued a presidential proclamation that sought to deny admission to the United States of “immigrant” foreign nationals that will “financially burden the United States healthcare system.” The proclamation effectively deems aliens seeking to immigrate permanently to the United States inadmissible unless they will be covered by “approved” health insurance within 30 days of their entry into the United States or have the financial resources to pay for “reasonably foreseeable” medical costs.

Several lawyers from our healthcare industry team recently attended HLTH in Las Vegas. HLTH provided a showcase for innovative ideas, platforms, and programs embracing the concept of “patient-centered care.”

This year’s event offered particular focus on innovations addressing the social determinants of care, elements of daily life that create barriers to receiving health services. As one executive of a large hospital system mentioned, they were reframing the institution’s vision around “health” and not “healthcare.” From programs in states partnering with ride-share apps to ensure Medicaid beneficiaries made their appointments, to highly integrated medical record and patient communication platforms designed to meet patients in their own space, there were numerous examples of business opportunities and legal challenges.

In Part 2 of a two-part Morgan Lewis series for Bloomberg Law on the proposed Stark Law and anti-kickback statute (AKS) rules, Kathleen McDermott, Matt Hogan, and Jacob Harper examine the safe harbors and exceptions aimed at empowering patients to manage their healthcare. Noting that value-based care can only be achieved when patients no longer sit on the sidelines, the authors ask whether the proposed AKS safe harbors are bold enough, and conclude there may be more that the Office of the Inspector General and the Centers for Medicare & Medicaid Services could do.

Read the full Bloomberg Law article >>

The US House of Representatives unanimously voted to approve HR 647, the Palliative Care and Hospice Education and Training Act (PCHETA), on October 28. This legislation would amend the Public Health Service Act to increase the number of permanent faculty in palliative care at accredited medical, nursing, and social work schools and other programs (including physician assistant education programs); promote education and research in palliative care and hospice; and support the development of faculty careers in academic palliative medicine. PCHETA now moves to the Senate where a similar measure, S 2080, has been referred to the Committee on Health, Education, Labor, and Pensions. However, given the fast approaching deadlines for Congress to fund the government and reauthorize expiring programs, this legislation may not receive attention in the near term. We will continue to monitor the bill’s progress and keep you apprised of any new developments.

Law clerk Ariel Landa-Seiersen contributed to this blog post.

With bipartisan bills introduced in both the US House of Representatives and the US Senate on October 30, Congress appears ready to expand access to telehealth benefits for Medicare beneficiaries. The Creating Opportunities Now for Necessary and Effective Care Technologies for Health Act of 2019 (CONNECT Act) may eliminate significant barriers Medicare beneficiaries currently face in accessing and utilizing telemedicine. The CONNECT Act acknowledges the potential for telehealth services to promote the “three pillars” of healthcare—expanding access, improving quality, and reducing spending—particularly at a time where healthcare workforce shortages make it difficult for many Medicare beneficiaries to access the care they need.

The Office of the Inspector General and the Centers for Medicare and Medicaid Services recently published a pair of proposed rules aimed at encouraging the adoption of value-based payment and care. In Part 1 of a two-part Morgan Lewis series for Bloomberg Law, Al Shay, Donna Clark, and Banee Pachuca unpack the proposed Stark Law exceptions and anti-kickback statute safe harbors that share similarities but differ in design when it comes to protecting physician compensation arrangements that advance value-based care. Potential challenges presented by the proposed rules with respect to obtaining safe harbor protection, encouraging payor participation, and absorbing downside financial risk are also addressed.

In addition, Al and Donna will be joining Jake Harper to talk about the Stark Law changes in more detail during our October 30 Fast Break—make sure to register!

Read the full Bloomberg Law article >>

The FTC announced on October 21, 2019, that its Commissioners voted 5–0 in support of issuing orders requesting information from five health insurance companies and two health systems to study the effects of Certificate of Public Advantage laws (COPAs) on price, quality, access, and innovation in the healthcare sector. The FTC has demanded an extensive amount of data from the targeted entities by January 21, 2020. Also notable in the FTC’s announcement is that the agency will study the impact of hospital consolidation on employee wages.

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 >