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Legal Insights and Perspectives for the Healthcare Industry

Our FDA team recently posted a LawFlash about the US Department of Health and Human Services (HHS) August 19 announcement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, in which it stated that the FDA would not require premarket review of laboratory developed tests (LDTs) without notice-and-comment rulemaking. The announcement has implications not only for LDTs intended for SARS-CoV-2 testing, but also for LDTs intended for other purposes, such as pharmacogenetic testing and direct-to-consumer testing.

Read the full LawFlash >>

In a stunning move, the Centers for Medicare and Medicaid Services (CMS) has linked reporting and tracking of the incidence and impact of the coronavirus (COVID-19) disease to satisfaction of the Medicare Conditions of Participation (CoPs) for hospitals and critical access hospitals, in spite of the federal about-face that has caused confusion concerning that same reporting since the inception of the pandemic.

CMS’s Interim Final Rule (IFR) applies to a large variety of healthcare and non-healthcare providers that are currently testing for coronavirus. Hospitals, employers, and other entities are struggling to ensure they comply with an ever-changing landscape of local, state, and federal reporting requirements. However, this recent IRF subjects these entities to fairly stout enforcement consequences for failure to stay current, comply, and perform. CMS released its IFR with comment for public display on August 25 with publication in the Federal Register on September 2, 2020. Comments are due 60 days after publication.

We are pleased to announce that we are participating in three upcoming digital health events.

Michele Buenafe, FDA partner and leader of our digital health initiative, will speak at two upcoming FDLI conferences focused on the Food and Drug Administration’s (FDA's) regulation of digital health and developments in digital health regulation before and beyond the coronavirus (COVID-19) pandemic, including significant enforcement discretion policies and exemptions FDA has implemented over the last six months.

On our next Fast Break webinar, Jake Harper will discuss updates in telehealth, a topic that has been top of mind for so many healthcare companies amid the COVID-19 pandemic. Register for Fast Break now.

Don’t forget you can check out all of our latest healthcare events and publications on Our Thinking on Healthcare.

Partners Ayesha Waheed and Asem Bakenova and associate Daniyar Zhumakhanov have contributed to the PFI Global Infrastructure Report 2020 with an article discussing Kazakhstan’s public-private partnership (PPP) law and its application to the healthcare sector.

In the article, they highlight a number of considerations related to private investment in Kazakhstan’s healthcare sector, which has seen a steady annual increase of 31% from 2016 to 2019.

Read the full article >>

Our global healthcare industry team continues to highlight how regions around the world have quickly adapted to providing telehealth services following the coronavirus (COVID-19) pandemic. In Singapore, telehealth providers are mainly focused on providing remote telemedicine and/or on-demand house call services.

We invite you to join us on Tuesday, August 25 for our next installment of the Fast Break series, this time focused on fraud enforcement following the coronavirus (COVID-19) pandemic.

Our labor, employment, and benefits team recently posted a LawFlash on the ruling in federal district court in New York that invalidated significant parts of a US Department of Labor rule. The ruling found that more employees are eligible for up to 12 weeks’ coronavirus (COVID-19)-related emergency paid sick leave and emergency paid FMLA leave. In light of the court’s decision, employers should consider whether they need to adjust their leave determinations in light of the court’s decision.

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As reported in As Prescribed, US President Donald Trump signed four executive orders implementing policies on drug pricing on July 24. One of the orders directs the secretary of the US Department of Health and Human Services (HHS) to condition future grants under Section 330(e) of the Public Health Service Act on Federally Qualified Health Centers establishing practices that ensure the 340B discount they receive on insulin and injectable epinephrine is passed through to low-income patients who lack insurance or have high copays or deductibles. The HHS secretary has discretion to set the standard for eligible patients.

In the blog post, Morgan Lewis senior counsel Donna Yesner reports that this policy is limited in scope to one category of covered entities—it does not extend to hospitals—and two categories of drugs, but is consistent with the legislative intent of the 340B program to make outpatient drugs accessible to poor and uninsured or underinsured patients of federal grantees. But, as with other drug pricing executive orders, there could be problems carrying out the 340B directive.

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Our immigration colleagues recently published a LawFlash on the July 29 decision by the US District Court for the Southern District of New York to grant a preliminary nationwide injunction to temporarily block the continued implementation of the public charge rule during a public health emergency such as the coronavirus (COVID-19) pandemic. Two days later, the US Citizenship and Immigration Services (USCIS) released a new proposed fee schedule with increased filing fees, set to take effect on October 2, 2020.

Read the LawFlash