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DOJ Announces Criminal Charges against Lab Executive Accused of Fraudulently Promoting COVID-19 Tests
June 11, 2020 | Blog | By Karen Lovitch , Rachel Yount
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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OTC Monograph Reform: Key Takeaways and What Industry Can Expect
June 10, 2020| Blog|
CMS Administrator Verma Calls for Permanent Expansion of Telehealth Access after COVID-19. Will States Follow Suit?
June 10, 2020 | Blog | By Cassandra Paolillo, Ellen Janos
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.
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FTC Comments on New Medicare Rule in Support of Expanded Telehealth Services
June 4, 2020 | Blog | By Evan Moore, Joseph Miller
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.
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FDA and FTC Continue to Trace and Fight Fraud Related to COVID-19
June 1, 2020| Blog|
Massive House Bill Proposes Mandatory Coverage of COVID-19 Vaccines and Therapies
May 18, 2020 | Blog | By Theresa Carnegie
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.
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CMS Allows Pharmacies and Other Suppliers to Bill Medicare for COVID-19 Testing
May 15, 2020 | Blog | By Karen Lovitch , Jane Haviland
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.
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OIG Updates Its COVID-19-Related FAQ Guidance to Okay Certain Specimen Processing Payments by Laboratories
May 12, 2020 | Blog | By Samantha Kingsbury
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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Next Steps for 21st Century Cures 2.0
May 8, 2020 | Blog
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.
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FDA Reverses Decision to Authorize Use of Chinese KN95 Respirators
May 8, 2020 | Blog | By Benjamin Zegarelli
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).
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Telehealth Reimbursement Continues to Expand for Medicare and Medicaid
May 6, 2020 | Blog | By Ellen Janos
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.
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Rough Seas for COVID-19 Serology Tests Lead to Course Correction by FDA
May 5, 2020| Blog|
FDA Expands Focus for COVID-19 Response
May 4, 2020 | Blog | By Benjamin Zegarelli
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.
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CMS Relaxes Medicare and Medicaid Ordering Requirements for COVID-19 Testing and Finalizes Coverage of Antibody Testing
May 1, 2020 | Blog | By Karen Lovitch , Rachel Yount
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.
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COVID-19 and Lab Testing: What’s the Story Behind the Story?
April 29, 2020| Blog|
OIG Publishes FAQs Addressing Application of Its Administrative Enforcement Authorities During the COVID-19 Public Health Emergency
April 28, 2020 | Blog | By Samantha Kingsbury, Karen Lovitch
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
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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FDA Continues Its Diverse Agency Actions in Response to COVID-19 Pandemic
April 22, 2020| Blog|
Seeking FCC Flexibility on the Sale of Wireless Medical Devices During COVID-19
April 22, 2020 | Blog
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.
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Viewpoint Editors
Karen S. Lovitch
Chair, Health Law Practice & Co-Chair, Health Care Enforcement Defense Practice
Joanne S. Hawana
Member
Rachel E. Yount
Of Counsel
Pat G. Ouellette
Associate
Stephnie A. John
Associate
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