Health Care

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.

On March 27, 2020, the President signed into law the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which in part describes reforms to modernize the regulatory framework for over-the-counter (OTC) monograph drugs. We previously blogged about the surprise addition of the OTC monograph reforms within the CARES Act. On May 29, 2020, the Office of Nonprescription Drugs within the Food and Drug Administration (FDA) held a webinar titled “Monograph Reform is Here!” (a recording of the webinar is available here), which included key highlights from the OTC monograph reform.

In an interview yesterday, CMS administrator Seema Verma expressed support for permanently expanding access to telehealth services after the COVID-19 public health emergency resolves. Here, we explore the nature and duration of the temporary executive and regulatory orders, emergency legislation, and sub-regulatory guidance, which have resulted greater access to telehealth while leaving a fair amount of uncertainty as to what the future of telehealth looks like.

On May 29th, the Federal Trade Commission (FTC) submitted a comment to the Centers for Medicare & Medicaid Services (CMS) in support of reducing reimbursement requirements for telehealth services. CMS accepted public comments for its new Interim Final Rule published on April 6, 2020, 85 FR 19230, which changes the Medicare payment regulations to allow for more flexible Medicare service options in response to the COVID-19 pandemic. In addition to supporting CMS’s new Interim Final Rule, FTC’s comment recommends permanent measures and further steps to take. The comment offers a valuable insight into the Commission’s stance on telemedicine in relation to health care competition.

We have been blogging about the various actions that numerous government agencies were taking to combat COVID-19 fraud (see here and here). These agencies and their respective law enforcement efforts have yet to slow down and appear to have accelerated as greater coordination begins to take root. As of May 29, 2020, the U.S. Food and Drug Administration (FDA) has issued 64 warning letters to companies making claims about a product alleged to be a COVID cure, treatment, or preventative product, while the U.S. Federal Trade Commission (FTC) had issued many, many more than that. In some cases, these warning letters are joint letters that come from both government agencies, which is never a good sign. The FTC in particular is making announcements on a regular basis about large batches of warning letters being issued, such as this one from May 21 highlighting that 50 more marketers of fraudulent COVID-19 products had received such a missive from the FTC. 

As the COVID-19 public health crisis continues, it is sometimes easy to forget what issues were at the forefront of our national conversation before the pandemic. It was mere months ago when Congress appeared to be edging closer to a deal on legislation addressing drug pricing. While the focus on drug pricing issues may have shifted of late, the American public’s access to drugs—and, more recently, vaccines—remains a critical public health issue, perhaps now more than ever. As Congress works feverishly to pass legislation to mitigate the effects of the COVID-19 crisis, it remains to be seen what will come of the various drug pricing proposals that were being debated earlier this session. For now, it looks like any legislative action to enhance patients’ access to drug therapies will likely come through a coronavirus-related stimulus bill, such as the one introduced by the House of Representatives last week.

In an effort to address the need to increase the availability of COVID-19 testing, the Centers for Medicare & Medicaid Services (CMS) has issued guidance notifying pharmacies and other Medicare-enrolled suppliers that they may temporarily enroll as independent clinical diagnostic laboratories during the COVID-19 public health emergency (PHE) so that they may bill Medicare for COVID-19 testing. 

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).

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.

On Monday, April 27, Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) announced the next steps for 21st Century Cures 2.0 (Cures 2.0), legislation that will build on the original 21st Century Cures Act enacted in December 2016 (Cures 1.0). While Cures 1.0 aimed to speed up the process of bringing new treatments to market, Cures 2.0 is generally envisioned to emphasize public health and streamlined care delivery, particularly in light of the COVID-19 pandemic. Elements envisioned to be in Cures 2.0 were outlined in a recently published concept paper that we discuss in this post.

Citing poor quality, the U.S. Food and Drug Administration (FDA) has barred the importation of certain KN95 filtering facepiece respirators manufactured in China. On May 7, 2020, FDA revised and reissued the Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China Emergency Use Authorization (EUA) that provided eligibility criteria authorizing the importation of respirators from China that are not approved by the National Institute for Occupational Safety and Health (NIOSH) (i.e., not certified as meeting the N95 standard).

Last week, the Centers for Medicare and Medicaid Services (CMS) announced additional waivers of limitations on Medicare reimbursement of telehealth services and updated its summary of COVID-19 blanket waivers. We’ve previously blogged about actions by CMS and other federal and state agencies to increase access to and encourage utilization of telehealth services during the COVID-19 pandemic through loosening of restrictions on telehealth reimbursement (see here and here). CMS is now taking additional steps to further these goals. Below is a summary of the major changes that CMS announced last week.

Responding to increased public and congressional criticism of its arguably too-flexible approach to regulatory oversight of serological tests used to detect COVID-19 antibodies, on May 4, 2020 the Food and Drug Administration (FDA) announced a revised policy aimed at reducing the risks associated with such tests.

The Food and Drug Administration (FDA) continues to churn out policy statements, guidance documents, and emergency use authorizations (EUAs) to address the COVID-19 public health emergency. At the outset of the pandemic in early 2020, the agency concentrated its efforts on measures relating to devices that may help directly diagnose, treat, or prevent COVID-19, such as facemasks, ventilators, and diagnostic test kits. Recently, however, FDA appears to have shifted its focus to devices that may assist in the defense against the spread of COVID-19. For example, FDA issued enforcement policies and EUAs that help to expand the availability and capability of various remote monitoring devices and systems that can be used to diagnose and monitor medical conditions while mitigating circumstances that could lead to patient and health care workers’ exposure to SARS-CoV-2 (the virus that causes COVID-19) for the duration of the public health emergency.

In an effort to increase access to COVID-19 testing for Medicare and Medicaid beneficiaries, the Centers for Medicare & Medicaid Services (CMS) has issued a second round of regulatory waivers that includes relaxed Medicare requirements for ordering COVID-19 diagnostic laboratory tests, flexibility for Medicaid coverage requirements of COVID-19 tests, and Medicare coverage of COVID-19 serology tests to identify antibodies.

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.

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.

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.

Since our last roundup-style blog post on the response of the Food and Drug Administration (FDA) to the COVID-19 public health emergency, the agency has taken a wide variety of additional actions with the goal of getting much-needed medical products into the hands of health care providers on the frontlines of the pandemic as it hits the United States hard. We’ve already covered recent FDA policy changes aimed at expanding the availability of face masks, face shields, and respirators (see prior post here), so today’s post will focus on other emergency actions outside of the personal protective equipment space. Mintz clinical laboratory experts are also preparing separate articles on the diagnostic and antibody testing issues ongoing with the COVID-19 response, so we are not going to discuss testing in today’s post either.

We’ve written previously about the role of the Federal Communications Commission (FCC) in regulating wireless medical devices, chiefly in determining the operating frequency and certain technical rules that ensure co-existence with other devices and wireless users. As part of that process, manufacturers must submit prototypes of new devices for testing and review by independent third party test labs and certification bodies (TCBs). The FCC prohibits responsible parties, such as manufacturers and resellers, from importing, marketing, or selling any device subject to this equipment approval process prior to obtaining approval from a TCB, which comes in the form of a grant of equipment certification.