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Senate HELP Committee Signals Support for Permanently Expanding Telehealth Access

June 24, 2020 | Blog | By Cassandra Paolillo, Ellen Janos

Last week, the Senate Committee on Health, Education, Labor & Pensions (“Senate HELP”) held a hearing entitled “Telehealth: Lessons from the COVID-19 Pandemic," during which the Committee members expressed support for permanently expanding access to telehealth services. In this blog post, we discuss the Committee's proposals and the additional steps needed to permanently expand access to telehealth.
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As we discussed in our last update on the Food and Drug Administration’s Comprehensive Regenerative Medicine Policy Framework back in December 2019 (during the much simpler, pre-COVID-19 world), this coming November will conclude the three-year period of enforcement discretion announced by the agency when it first articulated the policies and goals of this “comprehensive framework.” In particular, under the dual-track program announced in 2017, the Food and Drug Administration (FDA) has been focused on: (1) clarifying the regulatory criteria for product marketing through guidance and providing support to legitimate product developers through formal and informal interactions; and (2) removing unapproved, unproven, and potentially unsafe products from the U.S. market.
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COVID-19 Relief Programs: Mitigating and Responding To Enforcement Risk

June 22, 2020 | Blog | By Brian Dunphy, Jane Haviland, Nicole Henry, Karen Lovitch

Since the early days of the pandemic, Mintz’s COVID-19 Compliance & Enforcement Defense Task Force has closely monitored and advised clients on the evolving COVID-19 relief programs, including those created by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). The CARES Act provided for over $2 trillion in relief funds, which is the largest emergency assistance package in American history. The numerous CARES Act programs have continued to develop through, among other things, the passage of the Paycheck Protection Program and Health Care Enhancement Act, the Paycheck Protection Program Flexibility Act of 2020, and rapidly changing regulatory guidance and FAQs. As one example, the government recently wrestled with whether to make public the list of about 4.6 million entities that received more than $500 billion from the Paycheck Protection Program (PPP) under the CARES Act. After initially refusing to disclose PPP loan recipients, the Small Business Administration and Treasury Department decided to make public the names of entities that received loans larger than $150,000, as well as the dollar range of each loan.
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A panel of federal appellate judges has sided with drugmakers by upholding a lower court ruling from 2019 that struck down a regulation proposed by the Department of Health and Human Services (HHS). In a closely watched case, the United States Court of Appeals for the District of Columbia Circuit issued a decision on June 16, 2020 affirming the district court’s judgement that vacated the HHS Drug Pricing Disclosure Rule. This ruling is yet another example of a court invalidating the Drug Pricing Disclosure Rule, which sought to require drugmakers’ television advertisements to disclose the list prices of their prescription drug products.
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Late last week, the Department of Health and Human Services’ Office for Civil Rights (OCR) issued guidance aimed at “making sure misconceptions about HIPAA do not get in the way of a promising COVID-19 response,” according to OCR Director Roger Severino. That “promising response” relates to emerging evidence that plasma from recovered patients (often referred to as “convalescent plasma”) may contain antibodies to SARS-CoV-2, the virus that causes COVID-19. Those antibodies could be useful in treating individuals who are sick with COVID-19. The OCR’s guidance addresses how health care providers may 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.
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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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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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OTC Monograph Reform: Key Takeaways and What Industry Can Expect

June 10, 2020 | Blog | By Benjamin Zegarelli, Elizabeth Conti, Joanne Hawana

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.
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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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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. 
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Massive House Bill Proposes Mandatory Coverage of COVID-19 Vaccines and Therapies

May 18, 2020 | Blog | By Theresa Carnegie, Michelle Caton

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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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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FDA Reverses Decision to Authorize Use of Chinese KN95 Respirators

May 8, 2020 | Blog | By Benjamin Zegarelli, Elizabeth Conti

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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Next Steps for 21st Century Cures 2.0

May 8, 2020 | Blog | By Aaron Josephson

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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Telehealth Reimbursement Continues to Expand for Medicare and Medicaid

May 6, 2020 | Blog | By Sarah Beth Kuyers, 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 | By Joanne Hawana, Hope Foster, Aaron Josephson

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.
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FDA Expands Focus for COVID-19 Response

May 4, 2020 | Blog | By Benjamin Zegarelli, Elizabeth Conti

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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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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