According to a recent study (Study) published in Nature Reviews Drug Discovery on May 10, 2020 regarding the impact that the COVID-19 pandemic has had on the conduct of oncology clinical trials,[i] the COVID-19 pandemic has materially disrupted the conduct of clinical research and trials in much of the world. The observed disruptors include an observed decrease in patient enrollment in clinical trials and the operational challenges arising from the need to protect patient safety and comply with the social distancing, shelter-in-place and other rules and regulations that have become key elements of the public health response to the pandemic. As a result of these and other disrupters, investigators who participated in the Study reported that they are, “adopting or planning to adopt technology-based interventions aimed at reducing on-site monitoring visits and in-person patient visits to minimize potential viral exposure and spread, including telemedicine, remote electronic medical record access for monitors and virtual monitoring of data and study documentation.”
Continue Reading Going Virtual: Clinical Trials, Telemedicine, Electronic Medical Records, And All That.
Getting Ahead of California’s Post-Pandemic M&A Surge: California Senate Bill 977 Seeks to Expand Attorney General Oversight of Healthcare Acquisitions and Affiliations involving Hospitals, Health Systems, Private Equity Groups, and Hedge Funds
On May 18, 2020, California Senate Bill 977 (“SB-977”) was passed out of the California Senate Health Committee and is now scheduled for its first hearing before the Senate Appropriations Committee on June 1, 2020. SB-977 as written would subject all acquisitions and affiliations on and after January 1, 2021 by larger health systems, private equity funds and hedge funds of (i) hospitals, (ii) other health facilities, (iii) physicians, (iv) clinics, (v) ambulatory surgery centers or (vi) laboratories to prior approval by the California Attorney General. In its current form, SB-977 would require the California Attorney General to withhold his approval from a proposed transaction unless the transaction would (i) increase clinical integration and/or (ii) increase access or availability of healthcare services to underserved populations, and would not otherwise be anti-competitive. SB-977 would also give the Attorney General the discretion to hold a public hearing on a proposed transaction. In short, with SB-977, the California Legislature is going far beyond earlier proposals or legislation in other states – including Connecticut and Washington State – that have prior approval requirements for healthcare transactions.
In this article, we consider the forces behind SB-977 – a decade or more of healthcare consolidations and the financial distress being experienced by hospitals and other healthcare providers as a result of the current healthcare emergency – and the potential impact that SB-977 could have on the California healthcare marketplace if it were signed into law in its current form.
Continue Reading Getting Ahead of California’s Post-Pandemic M&A Surge: California Senate Bill 977 Seeks to Expand Attorney General Oversight of Healthcare Acquisitions and Affiliations involving Hospitals, Health Systems, Private Equity Groups, and Hedge Funds
Will COVID-19 Prompt “Holdout States” to Reconsider Medicaid Expansion?
In 2012, the U.S. Supreme Court in NFIB v. Sebelius struck down a provision in the Patient Protection and Affordable Care Act (the “ACA”) which, for all intents and purposes, made the expansion of the Medicaid program voluntary for individual states. As a consequence, the Medicaid expansion provided for in the ACA has been rolled out in piecemeal fashion, with various states opting to expand Medicaid in the years since the ACA’s passage, and other so-called “holdout” states choosing to preserve their respective pre-ACA structured Medicaid programs. These holdout states tend to be more conservative and Republican-controlled, with governors and state legislatures opposed to the ACA’s Medicaid expansion for various political and economic reasons. The COVID-19 pandemic, however, seems to have prompted some of these “holdout” states, even considerably conservative states, to reconsider their decision not to expand Medicaid.
Continue Reading Will COVID-19 Prompt “Holdout States” to Reconsider Medicaid Expansion?
The Expansion of Cardiovascular Procedures in the ASC Setting
In recent years, there has been a trend towards the provision of cardiovascular procedures in the outpatient setting and particularly in ambulatory surgery centers (“ASCs”). This trend is in part motivated by the fact that outpatient cardiovascular services, in comparison to cardiovascular services performed on an inpatient basis, tend to be less expensive and offer greater comfort and convenience for patients.[i] As a result of the emphasis on outpatient cardiovascular services, there is growing interest in the development and expansion of cardiovascular programs in ASCs.
Continue Reading The Expansion of Cardiovascular Procedures in the ASC Setting
COVID-19: Medical Liability for Expanded Scope of Services
As discussed in a prior blog post, in order to manage the unprecedented medical need due to the COVID-19 pandemic, some states have loosened scope of practice restrictions imposed on healthcare professionals. The relaxing of these restrictions has enabled registered nurses, nurse practitioners, physician assistants, pharmacists and other health care professionals to provide certain medical services that are outside the scope of practice permitted under the practitioner’s license during the COVID-19 crisis.
Continue Reading COVID-19: Medical Liability for Expanded Scope of Services
CMS Issues COVID-19 Prevention Guidance for PACE Organizations
On March 17, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued a memorandum to provide information to organizations that participate in the Programs of All-Inclusive Care for the Elderly (“PACE”) program in furtherance of preventing the spread of the 2019 Novel Coronavirus (“COVID-19”).
Continue Reading CMS Issues COVID-19 Prevention Guidance for PACE Organizations
Home Health Agencies and Dialysis Centers Take Note: CMS Provides Additional Guidance to Healthcare Providers to Stop the Spread of the Coronavirus
On March 10, 2020, the Centers for Medicare & Medicaid Services (“CMS”) supplemented the guidance that we previously discussed in our March 6, 2020 blog post in order to provide additional guidance to healthcare providers, specifically home health agencies and dialysis facilities, in addressing the spread of the 2019 Novel Coronavirus (“COVID-19”).
Continue Reading Home Health Agencies and Dialysis Centers Take Note: CMS Provides Additional Guidance to Healthcare Providers to Stop the Spread of the Coronavirus
CMS Announces Actions to Address the Threat of Coronavirus
On March 4, 2020, the Centers for Medicare & Medicaid Services (“CMS”) announced several measures aimed at preventing the spread of the Novel Coronavirus 2019 (“COVID-19”). Described by CMS Administrator Seema Verma as representing “a call to action across the health care system,” these actions serve to ensure health care facilities have updated information to be able to effectively respond to COVID-19 and thereby protect patients and residents.
Continue Reading CMS Announces Actions to Address the Threat of Coronavirus
340B Program-Participating Hospitals Object to CMS’s Proposed Cuts to 340B Program Reimbursement: CMS’s Recent Information Collection Request
Information Collection Request. On November 27, 2019, 340B Health, a nonprofit membership organization comprised of hospitals and health systems that participate in the federal 340B drug pricing program (“340B Program”), submitted comments (“340B Comments”) to Seema Verma, the Administrator of the Centers for Medicare & Medicaid Services (“CMS”), objecting to an announcement by CMS on September 30, 2019, which proposed an information collection request (“ICR”) to survey the drug acquisition cost data for hospitals participating in the 340B Program.
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Global and Professional Options Direct Contracting Model RFA and LOI Now Active
On April 21, 2019, the Center for Medicare and Medicaid Innovation (“CMMI”) announced the CMS Primary Cares Initiative – a voluntary, risk-based initiative to transform the Medicare program’s reimbursement of primary care services from a fee-for-service payment system to a value-based system that rewards physicians who keep patients healthy and out of the hospital. The CMS Primary Cares Initiative creates five payment models under two paths: the Primary Care First Model (“PCF Model”) and the Direct Contracting Model (“DC Model”). All five models focus on care for chronically and seriously ill patients.
Continue Reading Global and Professional Options Direct Contracting Model RFA and LOI Now Active