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Bioethics in a Pandemic: Vaccine Research and Clinical Trials

September 16, 2020 | Blog | By Bridgette Keller, Benjamin Zegarelli

After exploring some of the ethical questions involved in allocating and distributing a potential COVID-19 vaccine and the basic tenets of bioethics, we continue by delving into the ethical issues relating to the vaccine development process, including clinical trials. As a first step, we provide a very brief introduction on how vaccines are developed and tested prior to approval and release.
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On September 9, 2020, the Department of Justice (DOJ) announced a $50 million settlement with Wheeling Hospital, Inc. of West Virginia to resolve False Claims Act allegations that Wheeling Hospital violated the Anti-Kickback Statute (AKS) and Stark Law. The settlement resolved False Claims Act allegations that were triggered by a qui tam lawsuit brought by a former vice president of Wheeling Hospital who oversaw hospital operations and physician engagements. According to the relator's complaint, Wheeling Hospital, under its former management, paid several physicians annual compensation in excess of a million dollars based on the volume or value of their referrals.
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Bioethics in a Pandemic: The Public’s Role in COVID-19 Vaccination

September 9, 2020 | Blog | By Bridgette Keller, Michelle Caton

As we noted in our previous post, the Johns Hopkins University Center for Health Security (Center) has been hard at work studying and providing thought leadership regarding the COVID-19 pandemic from a variety of angles. The Center, in conjunction with Texas State University and the Working Group on Readying Populations for COVID-19 Vaccine, recently released a report exploring the public’s role in COVID-19 vaccination (Report). The Report provides recommendations to U.S. policymakers, practitioners, and other stakeholders about how to advance public understanding of, access to, and acceptance of vaccines that protect against COVID-19.
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Earlier this week, a committee of the National Academies sponsored by the CDC and NIH released its Draft Framework for Equitable Allocation of COVID-19 Vaccine. This Draft Framework builds on the successes and challenges of past vaccine allocation frameworks, as well as current frameworks for allocating scarce COVID-19 resources. This blog reviews these past frameworks that laid the foundation for the committee to develop its decision-making framework.
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CMS Announces One-Year Delay in Finalizing Highly Anticipated Stark Law Reform

August 27, 2020 | Blog | By Karen Lovitch, Rachel Yount

On Wednesday, August 26th, the Centers for Medicare & Medicaid Services (CMS) issued a notice extending the deadline to finalize significant proposed changes to the Physician Self-Referral Law (commonly known as the Stark Law) announced last year. CMS published the proposed rule on October 17, 2019 in tandem with a companion proposed rule issued by Department of Health and Human Services (HHS) Office of Inspector General (OIG) with equally sweeping changes to the Anti-Kickback Statute (AKS). Both rules were issued as part of CMS’s Regulatory Sprint to Coordinated Care and offer a number of industry-friendly changes designed to reduce regulatory burden associated with the Stark Law and the AKS and allow for increased adoption of value-based arrangements.
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Bioethics in a Pandemic: The Basics

August 26, 2020 | Blog | By Bridgette Keller, David Friedman

Before we continue our Bioethics in a Pandemic series, we thought it would be helpful to provide a quick overview of the various principles that inform ethical decision-making in the health care setting.

As you might imagine, providing health care to individuals with diverse background and values presents ethical choices for health care professionals every day, throughout the entire health care system – providers, administrators, policymakers, insurers, employers, and even the health care lawyers! Well-recognized bioethics scholars Tom Beauchamp and James Childress offer a principle-based approach to guide ethical decision-making in health care. The four principles are (1) Respect for Autonomy, (2) Nonmaleficence, (3) Beneficence, and (4) Justice.
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As we discussed in our previous blog post, the Department of Health and Human Services’ Office for Civil Rights (OCR) released guidance this past June to address how health care providers could contact, in a HIPAA-compliant manner, recovered COVID-19 patients to provide them with information about donating blood and plasma to potentially help other COVID-19 patients. On August 24, OCR released an updated version of that guidance to address similar communications from health plans. The amended guidance provides that health plans may also reach out to recovered COVID-19 patients about blood and plasma donation, subject to the same restrictions applicable to health care providers.
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About a month ago, I predicted on this blog that Food and Drug Administration’s November 2020 enforcement discretion deadline announced as part of its Comprehensive Regenerative Medicine Policy Framework would most likely not be extended. My view was based on a June 17 editorial by agency leadership discussing the risks of unapproved cellular therapy products, which didn’t suggest an extension was forthcoming, as well as an increase in Warning/Untitled Letters related to such products as compared to this time last year. In that earlier blog post I wrote: “Nothing in this newly published editorial suggests that [the Food and Drug Administration (FDA)] will be taking its proverbial foot off the pedal to slow down its efforts towards further oversight of the private stem cell clinic industry after November 2020.”
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OIG Approves Discount Medical Plan Referral Arrangement

July 6, 2020 | Blog | By Theresa Carnegie, Jane Haviland

On June 26, the Department of Health and Human Services Office of the Inspector General (OIG) issued Advisory Opinion No. 20-03 approving the payment by a discount medical plan organization (DMPO) of a five dollar ($5.00) fee to chiropractors for the referral of new members to the DMPO.  OIG determined that even though the arrangement could result in prohibited remuneration, it would not impose administrative sanctions or civil monetary penalties for violation of the federal Anti-Kickback Statute (AKS). 
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CMS Proposes Rule to Pave the Way for Value-Based Drug Purchasing

June 26, 2020 | Blog | By Theresa Carnegie, Ellyn Sternfield, Michelle Caton

The Centers for Medicare & Medicaid Services (CMS) has taken another step to further the adoption of value-based purchasing within the health care industry. (Readers may recall the Department of Health & Human Services’ two proposed rules – one from CMS and another from the Office of Inspector General – issued late last year, aimed at reducing barriers to value-based arrangements, which we discussed here.) CMS released its new proposed rule to “support state flexibility to enter into innovative value-based purchasing arrangements (VBPs) with manufacturers, and to provide manufacturers with regulatory support to enter into VBPs with payers, including Medicaid.”
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The Department of Justice (DOJ) has announced its first criminal securities fraud prosecution related to COVID-19, and it involves health care fraud as well. Mark Schena, president of Arrayit Corporation, a publicly traded medical technology company, faces criminal charges in connection with false and fraudulent claims submitted for allergy and COVID-19 testing. The complaint charges Schena with one count of securities fraud and one count of conspiracy to commit health care fraud. From 2018 to present, Arrayit, under Schena’s direction, allegedly submitted or caused the submission of over $5.9 million in Medicare claims and over $63 million in private insurance claims for allergy and COVID-19 tests that were not medically necessary, were not provided as claimed, or were tainted by the payment of kickbacks and bribes.
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A few weeks ago, we posted about a publication by the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) of responses to certain frequently asked questions (FAQs) received from the health care community regarding regulatory flexibility for providers that needed it to adequately respond to COVID-19 concerns.  This flexibility specifically relates to the OIG’s administrative enforcement authorities, including the federal Anti-Kickback Statute (AKS) and Civil Monetary Penalties Law prohibiting beneficiary inducement (Beneficiary Inducement CMPL).
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Earlier this month, Blue Bell Creameries L.P. (Blue Bell) agreed to plead guilty to charges that it distributed contaminated ice cream products that were linked to a 2015 listeriosis outbreak.  The Blue Bell outbreak made headlines in 2015, largely because it resulted in multiple cases of listeriosis and, tragically, three deaths.  Aside from the obvious health-related consequences to the public and reputational harm to the nationally-known manufacturer of sweet treats, the basis for the various charges and causes of action related to the outbreak demonstrate the broad range of legal consequences, both civil and criminal, that can result from the failure to address food safety requirements and regulatory compliance more generally.
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COVID-19 and Lab Testing: What’s the Story Behind the Story?

April 29, 2020 | Blog | By Hope Foster, Joanne Hawana

Recently, newspapers and television news programs have been full of stories about laboratory testing and the important role it will play in containing the spread of COVID-19 and reopening U.S. economic activity. But these stories have told a mixed tale. The Washington Post and The New York Times both ran front page stories on April 19, 2020 about how the Centers for Disease Control and Prevention (CDC) had bungled production of the first U.S. test kits for detecting the presence of the novel coronavirus by manufacturing them in a lab contaminated with the virus, according to the Food and Drug Administration (FDA). The FDA, which regulates test kits, testing materials, and testing instruments, had investigated the causes of its sister agency’s failure, which delayed by weeks the nation’s fight against the virus.

Only days before those stories ran, news outlets reported that Great Britain had paid $20 million to purchase antibody tests from China but, upon their arrival in Great Britain, those tests were found not to work. On April 26, 2020, the front page story in The New York Times headlined that “Testing Remains Scarce as States Weigh Reopening.”

Day after day, we have read conflicting stories about lab testing: do we have sufficient capacity and capability or do we not? If we do not, why don’t we? We have seen an alphabet soup of federal agencies named as being involved with clinical labs and working towards a solution to the many issues that have been raised. Having worked with labs for decades, we thought we would explore these really important questions. Which agency is responsible for what, and what are they doing? Every day we receive questions like these, and we thought that we would share what we have learned.
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On Friday, the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) issued responses to a series of frequently asked questions (FAQs), in an effort to provide some level of regulatory flexibility for health care providers responding to COVID-19 concerns.  These FAQs relate to enforcement of the OIG’s administrative enforcement authorities under the federal Anti-Kickback Statute (AKS) and Civil Monetary Penalties Law prohibiting beneficiary inducement (Beneficiary Inducement CMPL) only.
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In Case You Missed It: COVID-19 Webinars to Keep You Informed

April 24, 2020 | Blog | By Michelle Caton

The ongoing COVID-19 pandemic has introduced uncertainty and unique challenges in nearly every aspect of life. During this unprecedented time, Mintz is working to keep our clients and community informed and empowered to navigate this new world. To that end, we’ve created a number of webinars on a variety of COVID-19-related topics of interest to health care industry stakeholders. In case you missed them, here’s a highlights reel of what we’ve covered so far – just click on the links below to access the webinar recordings.
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As many of our readers know, as a result of the public health emergency caused by COVID-19, effective March 1, 2020, the U.S. Department of Health and Human Services (“HHS”) issued blanket waivers of its authority under Section 1877(g) of the Social Security Act (which authorizes the imposition of certain sanctions for violations of the Stark Law) with respect to 18 categories of remuneration and/or referrals (the “Blanket Waivers”).
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In response to the spread of COVID-19, on March 23, 2020, President Trump signed Executive Order 13910 (Order) to prevent the hoarding of health and medical resources necessary to respond to the spread of COVID-19 within the United States. Through the Order, the President delegated his authority under the Defense Production Act of 1950, 50 U.S.C. § 4512 (Act) to the Secretary of Health and Human Services (HHS). The Order authorizes HHS to protect scarce and threatened health care and medical items by designating particular items as protected under the Act (Designated Items). Once an item is designated, the Act makes it a crime for any person to accumulate Designated Items: (i) in excess of the reasonable demands of business, personal, or home consumption; or (ii) for the purpose of resale at prices in excess of prevailing market prices. In this post, we discuss four things to know in connection with the Order.
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Law Enforcement Stays Active During the COVID-19 Pandemic

April 13, 2020 | Blog | By Hope Foster

Last Tuesday, we blogged about the arrest of the owner of a Georgia-based marketing company who was charged with health care fraud and conspiracy to violate the Anti-Kickback Statute. The government has alleged that laboratories paid the company kickbacks for Coronavirus (COVID-19) testing leads.

The very next day, the United States Attorney’s Office in San Antonio, Texas charged 39 year-old Christopher Perez with allegedly perpetuating a COVID-19-related hoax by posting a false threat on Facebook in which he claimed to have paid someone to spread COVID-19 at grocery stores in Texas. These prompt actions to implement Attorney General William Barr’s March 16 call to prioritize the detection, investigation, and detection of all criminal conduct related to the COVID-19 pandemic caused us to wonder what the federal government is doing about enforcement. The answer is: a lot.
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The Department of Justice recently filed suit against Anthem, Inc. (Anthem) alleging that the Medicare Advantage Organization (MAO) violated the False Claims Act when it knowingly failed to delete inaccurate diagnosis codes submitted to the Centers for Medicare and Medicaid Services (CMS) for risk adjustment purposes. As predicated in our 2020 outlook post, we continue to see enforcement activity and ongoing litigation against Medicare Advantage plans. Notably, this trend is referenced in SDNY’s complaint, alleging that the government has “sought to enforce” data accuracy in the risk adjustment system by “actively pursuing legal remedies against [] MAOs that have knowingly submitted inaccurate and untruthful diagnosis data to CMS[.]” The complaint provides four examples of settlements obtained from 2012-2019 against MAOs and healthcare providers who, purportedly like Anthem, submitted inaccurate diagnosis codes to CMS or allegedly failed to delete unsupported diagnosis codes.
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