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On June 24, 2020, House Democrats proposed the Patient Protection and Affordable Care Enhancement Act (H.R. 1425) (the “Proposed Act”), legislation aimed at reinforcing the Affordable Care Act (the “ACA”) by: (i) lowering American’s health coverage costs; (ii) allowing Medicare to negotiate lower prescription drug prices; (iii) expanding coverage by incentivizing 14 holdout states to accept the ACA’s Medicaid expansion; (iv) expanding affordable coverage to vulnerable populations; (v) honing in on “junk” health plans that provide inadequate coverage; and (vi) strengthening protections for people with pre-existing health conditions. A fact sheet on the provisions of the Proposed Act is available…
On Thursday, June 11, 2020, the U.S. House Select Subcommittee on the Coronavirus Crisis,[1] chaired by Rep. James E. Clyburn, held a video briefing (the “SCC Briefing”) with experts and affected individuals to examine the impact of the COVID-19 pandemic on nursing home residents and workers.…
According to an April 13, 2020 Press Release issued by the National Association of ACOs (“NAACOS”),  a recent NAACOS survey shows that 56% of the survey-participating at-risk accountable care organizations (“ACOs”) – i.e., ACOs participating in a Center for Medicare and Medicaid Innovation (“CMMI”) alternative payment model (“APM”) and assuming financial risk thereunder – said that they were likely to drop out of their APM because of their fear of having to cover massive losses resulting from the COVID-19 pandemic.  In addition, the survey revealed that, as a result of swings in unpredictability and spikes in expensive hospitalizations, 21% of…
Last week, new legislation was introduced in the U.S. House of Representatives that would require Medicare to reimburse certain telehealth services post the public health emergency period.  If passed, the bipartisan  Helping Ensure Access to Local TeleHealth Act of 2020 or HEALTH Act of 2020 (the “HEALTH Act of 2020”) would codify Medicare reimbursement and allow reimbursement for telehealth services provided by federally qualified health centers (“FQHCs”) and rural health clinics (“RHCs”).…
On November 15, 2019, CMS issued a final rule that requires hospitals to disclose to patients the hospital’s “standard charges,” which include the reimbursement rates the hospitals negotiate privately with insurers.  This rule is in line with President Trump’s Executive Order, dated June 24, 2019, which focused on increasing price and quality transparency for American healthcare consumers.  The Final Rule goes into effect as of January 1, 2021, at which time hospitals will have to post their standard charges online.  Any hospital that refuses to do so will be subject to a fine of up to $300 per day.  While…
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 Coronavirus Aid, Relief, and Economic Security (CARES) Act provided trillions in economic relief in response to the COVID-19 pandemic, including hundreds of billions of dollars in aid for the healthcare industry.  Regulators in the healthcare industry have also adjusted regulations and procedures in response to the changing landscape caused by the pandemic.  While the CARES Act and regulatory changes provide much-needed help, accepting funds and navigating the regulatory changes can add many legal pitfalls to an already cluttered regulatory scheme.  As the government prepares to prosecute fraud and abuse by recipients of CARES Act funds, healthcare entities—the top payors…
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…
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…
On April 27, Sheppard Mullin and Citrin Cooperman released a white paper entitled “Telehealth Development: Addressing the Current Need, While Strategically Position for the Future” addressing how federal and state regulators are promoting the expansion of telehealth. Healthcare organizations, of all types and sizes, are working to respond to the rapidly-changing regulatory environment. While there is uncertainty as to what extent these regulatory changes will remain in effect following the public health emergency period, it will be critical for all healthcare organizations to establish a strong foundation for a more permanent telehealth strategy after the crisis is over.…
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.…
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.…
As we discussed in our April 27, 2020 blog post, nursing homes have become the focus of significant attention during the COVID-19 crisis.  In many respects, the attention is well deserved: Nursing homes traditionally serve seniors who often struggle with chronic health conditions. As a result, nursing home residents are particularly vulnerable to coronavirus infection due to both their age and health status; Nursing homes residents are highly interactive with each other. The close proximity of nursing home rooms/beds and the personal relationships often formed among nursing home residents make social distancing hard to maintain; In order to relieve…
As the COVID-19 emergency continues to heavily impact the U.S. and its health care system, CMS has issued additional flexibilities for providers and payors seeking to respond to the pandemic.  These new flexibilities are described both in revisions to CMS’ blanket waivers and in a new Interim Final Rule with comment period, both issued on April 30.  Many of these flexibilities are responsive to questions and requests submitted to CMS over the past few weeks, providers’ experiences with developing and implementing pandemic response plans, and the regulatory obstacles they have encountered.  While these new flexibilities will not eliminate all of…