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DOJ Files False Claims Act Lawsuit Against Anthem for “One-Sided” Chart Review Practices
April 7, 2020 | Blog | By Brian Dunphy, Nicole Henry
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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A Review of the Affordable Care Act at 10 Years
April 6, 2020 | Blog | By Xavier Hardy
Two weeks ago marked the tenth anniversary of the enactment of the Affordable Care Act (ACA). Given the ongoing COVID-19 pandemic, which Mintz has been closely monitoring, it is understandable why the anniversary has largely flown under the radar. However, now is as good a time as any to reflect on all the controversy that has surrounded the law over the last decade, as well as how much the law has accomplished. While far from comprehensive, our upcoming blog series will review some of the impacts the law has had on the U.S. healthcare system, in particular focusing on the legal issues and debates that have surrounded the law. Mintz has previously covered many of these items, and links to our prior coverage is included throughout.
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And Now For Something Completely Different: FDA Actions to Alleviate Regulatory Burdens For Product Sponsors During the COVID-19 Pandemic
April 6, 2020 | Blog | By Joanne Hawana
We’ve been blogging periodically on the various actions taken and enforcement policies being developed by the Food and Drug Administration (FDA) to support and expand the national response to the declared COVID-19 public health emergency. At the same time, however, the agency has also been taking various steps to help medical product sponsors and consumer product manufacturers and distributors prioritize their ongoing regulatory compliance activities during this challenging period for business-as-usual.
As we’ve already covered in depth (see prior post here), on March 18, 2020 the agency issued guidance for clinical trial sponsors regarding how to ensure the continued safety and informed consent of human subjects. That critical guidance document was updated on March 30 to add a new appendix with common sponsor questions, and FDA has stated that it plans to further update the appendix as new questions arise. Over the past several weeks, the agency has issued the following important policies on other issues that also seek to provide some much-needed regulatory relief to FDA-regulated manufacturers and distributors.
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As we’ve already covered in depth (see prior post here), on March 18, 2020 the agency issued guidance for clinical trial sponsors regarding how to ensure the continued safety and informed consent of human subjects. That critical guidance document was updated on March 30 to add a new appendix with common sponsor questions, and FDA has stated that it plans to further update the appendix as new questions arise. Over the past several weeks, the agency has issued the following important policies on other issues that also seek to provide some much-needed regulatory relief to FDA-regulated manufacturers and distributors.
Barriers to Telehealth Continue to Fall After CARES Act and Other Federal and State Actions
April 3, 2020 | Blog | By Ellen Janos
As we’ve previously discussed on the blog, telehealth is playing a critical role in delivering care during the COVID-19 pandemic. Both Congress and states continue to take action to expand the use and reimbursement of telehealth services. The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) passed by Congress last Friday includes many provisions that further expand the use and reimbursement of telehealth during this public health emergency. Congress previously took action to start waiving certain telehealth requirements in the Coronavirus Preparedness and Response Supplemental Appropriations Act (Appropriations Act) passed on March 6, 2020, which we previously discussed here. In this post, we’ll cover the key ways that the CARES Act continues to remove barriers to telehealth, in addition to other recent federal and state actions.
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Ninth Circuit Joins Several Others in Finding that Lack of Medical Necessity Claims Can Proceed Under the False Claims Act
April 2, 2020 | Blog | By Samantha Kingsbury
The Ninth Circuit Court of Appeals recently allowed a False Claims Act (FCA) case based on an alleged lack of medical necessity to proceed, rejecting the lower court's decision that subjective medical opinions about the necessity of hospitalization cannot be "objectively false." The Ninth Circuit joins several other circuits (including the Third Circuit, which recently issued the Druding decision that we posted about a few weeks ago) in reaching this decision, which has been a rapidly evolving area of FCA law.
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Five Suggested Updates for 340B Covered Entities Facing COVID-19 Challenges
April 2, 2020 | Blog | By Daryl Berke
The Health Resources and Services Administration (HRSA) recently published guidance regarding the evolving impact of COVID-19 on 340B stakeholders. This new guidance is one part of the U.S. Department of Health and Human Services’ broader effort to maximize regulatory flexibility for health care providers scrambling to meet patient needs during the COVID-19 crisis. While HRSA’s new guidance begins by acknowledging “it is appropriate to take into account the realities of the COVID-19,” HRSA offers little in the way of substantive relief when it comes to 340B. Long on generalities and short on specifics, HRSA merely advises entities to ensure they “have policies and procedures in place to address the proper dispensing of 340B drugs.”
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CMS Releases Several Stark Law Waivers for Use during the COVID-19 National Emergency
April 1, 2020 | Blog | By Theresa Carnegie, Rachel Yount
On March 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued blanket waivers to the Stark Law that permit certain arrangements between physicians and health care providers implemented in response to COVID-19 that would otherwise violate the Stark Law. The waivers, which are numerous and fairly broad, offer health care entities significant flexibility to combat COVID-19 in ways that may have otherwise violated the Stark Law, such as the ability to pay physicians hazard pay and provide personal protective equipment to physicians at a price that is below fair market value (FMV). Importantly, the waivers only apply to remuneration and referrals related to COVID-19 purposes.
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FCC Chairman Proposes Plan to Implement CARES Act Funding for Telehealth Program
March 31, 2020 | Blog | By Jane Haviland, Ellen Janos
On Monday, FCC Chairman Ajit Pai circulated a plan to his fellow Commissioners detailing how the $200 million the agency will receive via the CARES Act should be deployed for a telehealth program to combat COVID-19. The telehealth program will enable eligible healthcare providers to purchase telecommunications, broadband connectivity and information services, and devices necessary to provide telehealth services to beneficiaries. The increased access to the tools needed to provide care via telehealth will allow COVID-19 patients to receive care and providers to give it, while reducing opportunities for further exposure.
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Coronavirus Relief Bill Includes Surprise Addition: OTC Monograph Reform Bill Becomes Law
March 30, 2020 | Blog | By Joanne Hawana
As a follow up to our recent blog post, FDA User Fees: Highlights from FDARA & Our Forecast for the Next Round, President Trump signed the bipartisan over-the-counter (OTC) monograph teform bill into law on March 27, 2020. The passage of the OTC monograph reform bill is a surprise addition into the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), the third COVID-19 stimulus bill enacted since the pandemic began. The reform legislation represents the first significant update to federal oversight of OTC drug products since 1972. It enables the Food and Drug Administration (FDA) to quickly respond to safety concerns and keep pace with innovation in hopes of protecting consumers from unsafe drugs and permitting manufacturers to market new products more expeditiously.
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FDA Creates Regulatory Exemptions for Face Masks and Respirators in Response to the Spread of COVID-19 and Critical PPE Shortages
March 27, 2020 | Blog | By Benjamin Zegarelli
On March 25, 2020, the Food and Drug Administration (FDA) issued a temporary policy relating to enforcement of regulatory requirements for face masks and respirators during the COVID-19 crisis. Since the public health emergency began, the United States has experienced a shortage of masks, respirators, and other personal protective equipment (PPE) which are critically needed for health care workers caring for COVID-19 patients in all states. FDA previously created emergency use authorizations (EUAs) for NIOSH-approved disposable respirators for use in health care settings and imported non-NIOSH-approved disposable respirators, but the temporary enforcement policy represents an attempt to open the manufacturing, importation, and distribution flood gates to make more masks and respirators available as quickly as possible.
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Boards of Pharmacy Nationwide Respond to COVID-19 Pandemic
March 26, 2020 | Blog | By Rachel Yount
In response to the nationwide COVID-19 emergency, state boards of pharmacy across the country are authorizing waivers of specific provisions of pharmacy laws and implementing policies to address potential staffing shortages and emergency dispensing of pharmaceuticals. Here's a high-level overview of the various actions being taken by state boards of pharmacy.
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CMS Offers Unprecedented Flexibility in Medicare Enrollment Requirements in Light of the COVID-19 Pandemic
March 25, 2020 | Blog | By Karen Lovitch, Jane Haviland
As authorized by Section 1135 of the Social Security Act, the Centers for Medicare & Medicaid Services (CMS) has announced that it will extend temporary Medicare billing privileges to physicians and non-physician practitioners via telephone and that it will expedite pending enrollment applications submitted by all other providers and suppliers, including DMEPOS. CMS made the announcement on March 13th and followed up with the publication of FAQs related to enrollment relief earlier this week.
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Public Safety and Fraud During the COVID-19 Outbreak: Will Congress Take Action?
March 25, 2020 | Blog
Yesterday, we blogged on how scammers are trying to monetize on the COVID-19 health crisis for their personal gain. Though the U.S. Food & Drug Administration (FDA) issued a consumer update yesterday saying that there is still no approved vaccine or drug to prevent or treat this disease, companies have continued to market products that claim to prevent, treat, or even cure COVID-19 in an attempt to “help” or profit from distressed, vulnerable Americans. While the FDA is working tirelessly to review possible vaccines, treatments, and cures, Americans should avoid endangering their health or lives by self-medicating. Per the FDA, self-medicating with any new product on the shelf (real or virtual) could not only lead to adverse effects but also could interfere with crucial medications. We are closely monitoring whether Congress will take specific actions on these increasingly prevalent issues in the context of the COVID-19 pandemic.
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COVID-19 Fraud Alerts and Government Actions
March 24, 2020 | Blog
In the past couple of days, the Department of Health and Human Services Office of Inspector General (HHS-OIG) and the Department of Justice (DOJ) each issued warnings about fraudulent schemes relating to COVID-19. While we are all taking precautions to stay safe and #flattenthecurve -- with many under orders to shelter in place -- scammers are preying on fears and insecurities and hawking test kits and vaccines for the virus. These scams are reminders to trust our medical professionals and access them when we feel sick and to think twice when something sounds too good to be true.
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FDA Issues Guidance Addressing COVID-19 Interference with Clinical Trials
March 21, 2020 | Blog | By Dianne Bourque, Benjamin Zegarelli
In recognition of the widespread disruptions the COVID-19 crisis is posing to planned and ongoing clinical trials at sites throughout the United States (and global clinical sites), the Food and Drug Administration (FDA) issued on Wednesday, March 18 a guidance describing potential considerations for adjusting trial processes and, potentially, protocols and statistical analysis plans to mitigate any difficulties meeting trial objectives due to interference from the virus and related social and governmental restrictions. The document, titled FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic, describes various potential complications, such as subjects being unable to travel to the trial site, loss of access to investigational product, or the need to screen subjects for COVID-19, as well as general recommendations for addressing them.
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Effects of Social Distancing and COVID-19 on Government Investigations & Proceedings Still Developing
March 20, 2020 | Blog | By Samantha Kingsbury
In the midst of the upheaval caused by social distancing and related efforts to minimize and contain COVID-19-related risks, we have been monitoring steps taken by the Department of Justice (DOJ), the U.S. Attorneys’ Offices (USAOs), and federal courts to adapt to these circumstances. Any steps taken are sure to affect ongoing government investigations and related proceedings and how we, as defense counsel, approach them.
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OCR Exercises HIPAA Enforcement Discretion for Telehealth Services During the Coronavirus Emergency
March 19, 2020 | Blog
The Department of Health and Human Services (HHS) has taken many actions to loosen or waive requirements on the provision of health care during the current coronavirus pandemic, as we discussed yesterday and Tuesday. In addition to HHS’s waiver of certain HIPAA requirements, HHS’s Office for Civil Rights (OCR) recently announced that it will not be imposing penalties for providers who use communication devices or other technologies that do not meet HIPAA’s requirements in order to treat patients via telehealth.
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Congress and the White House Continue Efforts to Respond to Coronavirus
March 19, 2020 | Blog | By Anthony DeMaio
The response to the coronavirus situation is fluid and fast-moving – particularly by Congress’ standards. In response to the coronavirus pandemic, three phases of legislation have been considered in Congress: Coronavirus Supplemental Appropriations Act (signed into law March 6th); Families First Coronavirus Response Act (signed into law March 18th); and a large ($1 trillion+) economic recovery package (currently being drafted). This post provides details about these legislative efforts and other recent actions by the White House to address the coronavirus pandemic.
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HIPAA Compliance in a National Emergency: What Does It Look Like in Real Life?
March 18, 2020 | Blog | By Dianne Bourque
Amidst the novel coronavirus (COVID-19) outbreak, the Secretary of the U.S. Department of Health and Human Services (HHS), Alex M. Azar, took steps on March 15, 2020, to waive sanctions and penalties related to certain provisions of the HIPAA Privacy Rule (the “Waiver”). However, the HIPAA Privacy Rule is not suspended, and the Waiver only applies: (1) in the emergency area identified in the public health emergency declaration; (2) to hospitals that have instituted a disaster protocol; and (3) for up to 72 hours from the time the hospital implements its disaster protocol. To demonstrate how the Privacy Rule and Waiver provisions work in real life, let’s look at an example: A patient at a hospital reports contact with a confirmed COVID-19 diagnosis. How can this information be shared?
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FDA’s Ongoing Response to the COVID-19 (Coronavirus) Outbreak
March 18, 2020 | Blog | By Joanne Hawana, Benjamin Zegarelli
As we write this update on the actions of the Food and Drug Administration (FDA), more state and local governments (along with private businesses and employers) are taking sweeping actions to protect the public from the continued spread of COVID-19. The federal response to what is now a pandemic of COVID-19 started off slowly, but we are now seeing frequent and promising announcements from FDA and other agencies within the Department of Health and Human Services.
We published our first installment highlighting FDA’s role in this public health emergency on March 4, 2020 (see our prior post here). In the two weeks that have elapsed since then, FDA has taken several actions related to COVID-19 testing and other important public health protections which are explained below. One of the most striking things about the list of actions included in this post may be how diverse and broad FDA’s authorities are and what a substantial role the agency plays in protecting Americans from a variety of different types of harm.
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We published our first installment highlighting FDA’s role in this public health emergency on March 4, 2020 (see our prior post here). In the two weeks that have elapsed since then, FDA has taken several actions related to COVID-19 testing and other important public health protections which are explained below. One of the most striking things about the list of actions included in this post may be how diverse and broad FDA’s authorities are and what a substantial role the agency plays in protecting Americans from a variety of different types of harm.
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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