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What We’re Reading - July 23, 2021

July 23, 2021 | Blog | By Cynthia Larose

There is a glut of information out there regarding privacy and cybersecurity these days.  Our new feature “What We’re Reading” provides a curated list of articles, blogs, newsletters, and books that you may find interesting and helpful.
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Meet Scott Thompson: Battling for the Wireless Infrastructure Industry in Cities and in Courts

Mintz Member and Chair of the firm’s Communications Infrastructure Litigation Practice, Scott Thompson, was profiled as an industry leader by the Wireless Infrastructure Association. In the blog post, Mr. Thompson reflected on making a major career move by joining Mintz in the middle of a global pandemic, his 20+ year career path and high profile cases, and the most significant issues facing the wireless infrastructure industry today and in the near future.

Source

Wireless Infrastructure Association

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In this episode of the EXCLUSIVE RIGHTS: Intellectual Property podcast, Mintz IP attorneys Drew DeVoogd and Daniel Weinger welcome guest David Duski for the first of a two-part series covering patent trial damages.
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Four Mintz Members Recognized by Benchmark Litigation’s 40 & Under Hot List 2021

Mintz is pleased to announce that four Litigation Members have been named to Benchmark Litigation’s 40 & Under Hot List 2021. The annual ranking recognizes the best and brightest law firm partners under 40 in the United States and Canada who stand out due to their high-stakes wins, precedent-setting matters and positioning for future success. 

The following Mintz attorneys were selected for inclusion in their respective practice areas: 

Mr. Frey is a skilled litigator that advises clients on a broad range of disputes involving commercial real estate and government regulation. He has extensive experience litigating complex lease disputes, commercial evictions, permits/zoning appeals, tax abatements, property valuations, government investigations, and administrative proceedings before state and federal agencies.

Mr. Hupart’s practice encompasses complex commercial litigation, including cases involving securities, employment, and environmental claims, as well as class action litigation, white collar criminal defense, and regulatory investigations. Mr. Hupart has extensive experience representing clients in a variety of industries, including financial services, energy, education, and the media.

Ms. Musgrave is Co-Chair of the firm’s Appellate Practice Group. She leads clients through the appellate process, designing a successful appellate strategy, drafting briefs, and preparing for oral argument. She also assists clients with amicus curiae submissions, including to the U.S. Supreme Court. Working as a litigator both at the trial and appellate phases, her practice focuses on complex commercial litigation across a variety of areas, including contract disputes, securities litigation and government investigations.

Alec has significant experience advising directors, officers, members, managers, and shareholders of closely-held businesses regarding their fiduciary duties, corporate governance, and indemnification rights and responsibilities. He also litigates and advises insurers concerning complex coverage issues. Alec is well-known for his pro bono work in Massachusetts, which focuses primarily on representing survivors of sex trafficking and domestic violence and raising awareness of legal issues impacting survivors of human trafficking.

Benchmark Litigation is the definitive guide to the world’s leading litigation firms and lawyers. The law firm and lawyer rankings are based on extensive interviews with litigators, dispute resolution specialists and their clients as well as analysis of the market’s most important cases and firm developments.

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On June 24, 2021, the Food and Drug Administration (FDA) issued the long-awaited Remanufacturing of Medical Devices Draft Guidance, which describes the agency’s current thinking on activities that meet the definition of remanufacturing and a process for determining whether an act done to an original equipment manufacturer’s (OEM’s) legally marketed finished device is considered remanufacturing (the “Draft Remanufacturing Guidance”).
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Trio of Firm Attorneys Receive 2021 Richard Mintz Pro Bono Award for Partnership with Lawyers Clearinghouse to Establish Criminal Record Sealing Clinic

Mintz is pleased to announce that firm attorneys Nicholas Armington, Nadia Do Canto, and Rithika Kulathila have received the 2021 Richard Mintz Pro Bono Award, which is presented annually on behalf of the firm by Mintz’s Pro Bono Committee to attorneys who demonstrate exemplary commitment to pro bono work. The trio of honorees was recognized for their efforts with legal services nonprofit and the firm’s longstanding pro bono partner Lawyers Clearinghouse to establish a Massachusetts Criminal Offender Record Information (CORI) sealing clinic. The attorneys were celebrated virtually during the firm’s 30th annual Pro Bono Award reception held on July 12.

Mr. Armington, Mrs. Do Canto, and Ms. Kulathila initiated a successful partnership with Lawyers Clearinghouse and the City of Boston to establish a virtual clinic that helps low-income residents seal or expunge criminal records. This groundbreaking program is especially important in addressing the disproportionate impact the criminal justice system has had on Black men and other communities of color in Boston. By collaborating with Mintz’s partners on this clinic, Mr. Armington, Mrs. Do Canto, Ms. Kulathila, and other firm attorneys have helped individuals throughout Greater Boston remove significant barriers that would have made it difficult for them to pursue future employment, housing, and educational opportunities.

The virtual Pro Bono Award reception was punctuated by congratulatory remarks from firm leaders including Member and Chairman of the firm Robert Popeo, Managing Member Bob Bodian, and Member and Chair of the Pro Bono Committee Susan Finegan. In addition, Susan Gedrick, Executive Director of Lawyers Clearinghouse, and Crispin Birnbaum, a Lawyers Clearinghouse Access to Justice Fellow, joined to reflect on Mintz’s pro bono partnership over the past 27+ years and the impact of this latest collaboration to serve individuals in need through the CORI sealing clinic.

“This has been a challenging year for many, and in particular for our pro bono clients in vulnerable and low-income communities,” said Ms. Finegan. “The Pro Bono Committee has been greatly impressed by the enthusiasm and commitment of this group – Nick, Nadia, and Rithika – to tackle systemic racism through the CORI sealing clinic. Due to their leadership, the project has been a huge success at Mintz, with 32 attorneys and professional staff helping over 30 individuals to seal their criminal records throughout the last year.”

During the event, all three Richard Mintz Pro Bono Award honorees shared their experience and impressions of the CORI sealing clinic and encouraged their colleagues to volunteer a relatively small amount of their time to make a lasting difference in someone’s life.

The Richard Mintz Pro Bono Award is named in honor of Richard Mintz, the son of one of the firm’s founders, who in many ways embodied the generous spirit of Mintz and was a strong supporter of the firm’s pro bono contributions.

Pro bono service is at the heart of Mintz’s culture and identity. The firm partners with nonprofits, legal services organizations, in-house legal departments, and other law firms to provide life-changing assistance for individuals in need. Significantly, in the past year, more than 400 Mintz attorneys contributed to over 300 unique pro bono matters. To learn more about the firm’s pro bono work, please click here.

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To note the one year anniversary of the California Consumer Privacy Act (CCPA) enforcement date, California Attorney General Rob Banta held a press conference on July 19, 2021 to share key information about enforcement efforts and announce a new consumer privacy tool. He also praised businesses for their prompt compliance efforts and urged consumers to be proactive about their privacy rights.
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Mintz Continues Washington, D.C. Growth, Relocates to and Expands Office Space at the Thurman Arnold Building

Mintz announced today the relocation of its office in Washington, D.C. to accommodate the firm’s continued strategic expansion. The firm has moved into the Thurman Arnold Building, occupying 57,000 square feet of office space at 555 12th St., NW, a nearly 782,000-square-foot building by F and 12th Streets NW.

“As we continue to expand the firm’s capabilities to better serve the needs of our clients, a new office in D.C. became a priority. Just in the last year D.C. has added 13 lawyers,” said Susan Berson, Managing Member of Mintz’s Washington, D.C. Office and Chair of the firm’s Health Law, Communications, Antitrust & ML Strategies Division. “The state-of-the-art Thurman Arnold Building provides us with a modern, technologically advanced workplace designed to facilitate collaboration with each other and with our clients, and offers a host of additional amenities. While the new space meets the firm’s needs today, it is also flexible to adapt to its future needs.”

Mintz opened an office in Washington, D.C. in 1979, headed by Charles D. Ferris, former Chairman of the Federal Communications Commission (FCC). Since then it has grown to more than 70 attorneys and ML Strategies government consultants, focused primarily on federal regulation, legislation, and litigation, with an emphasis on communications, the environment, health care, and antitrust. 

Spanning one city block, 555 12th St. NW, known as the Thurman Arnold Building, is located in Washington, D.C.'s historic downtown. With an exceptional location between Capitol Hill and the White House, the building boasts immediate access to seats of power and those advising policy makers and true agents of change. In addition to being named a “showcase project” by the Better Buildings Initiative of the U.S. Department of Energy (DOE) for its technology upgrades, 555 12th Street is also certified LEED Gold.

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On Friday, July 9th, President Biden released an Executive Order “to promote competition in the American economy” and to “to reduce the trend of corporate consolidation” (the “Order”). As part of this Order, the Biden Administration specifically targets competition in the pharmaceutical industry and sets forth policies to combat the high cost of prescription drugs. As the Administration’s first major policy initiative on drug pricing, this Order may serve as a preview of the Administration’s drug pricing reform agenda. For additional information about the Executive Order, please see our Antitrust colleagues' alert on the Order's initiatives specifically earmarked for the Federal Trade Commission and the Department of Justice’s Antitrust Division.
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How Western States Help The Wealthy Avoid Taxes, Creditors

Daniel Pascucci, Managing Member of Mintz’s San Diego office and Co-Chair of the firm’s Cross-Border Asset Recovery Practice, authored a Law360 expert analysis article spotlighting the growing allure of Western states as asset havens, highlighting the need for creditors and claimants to consider robust U.S. enforcement strategies in asset-recovery efforts.

Source

Law360

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In the latest development in the Department of Justice (DOJ) Antitrust Division’s ongoing investigation into the generic pharmaceutical industry, Heritage Pharmaceuticals, Inc. has entered into a deferred prosecution agreement (DPA) with DOJ. The terms of the DPA require Heritage to pay a $225,000 criminal penalty and provide full cooperation with the ongoing investigation. The one-count felony charge, filed in the Eastern District of Pennsylvania on May 30, alleges that Heritage violated Section 1 of the Sherman Act by conspiring with multiple unnamed parties to divide up the domestic market and fix prices for glyburide, a diabetes medication, from April 2014 through December 2015. According to DOJ, the DPA provides that the United States will not prosecute Heritage for three years.
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Earlier this week the OIG took the somewhat unusual step of issuing a fraud alert directed to Medicare beneficiaries (rather than to Medicare providers) regarding “fraud schemes” that involve genetic testing. According to the OIG, beneficiaries are being offered genetic tests in order to obtain their Medicare information, which is then used to commit identity theft or to submit fraudulent claims to Medicare. Beneficiaries are being targeted through telemarketing calls, booths at public events, health fairs, and door-to-door visits.
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CMS Finalizes Medicare Advantage and Part D Drug Pricing Rule

May 28, 2019 | Blog | By Bridgette Keller, Daryl Berke, Lauren Moldawer

Earlier this month, CMS issued a final rule aimed at lowering drug prices and reducing out-of-pocket expenses in Medicare Advantage and Medicare Part D. This rule is the Administration’s latest effort to address prescription drug prices and builds off the Administration’s Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs and arrive on the heels of CMS publishing a rule requiring the disclosure of drug prices in TV ads. Below we’ve provided a brief overview of the major provisions in the final rule, noting changes from the proposed rule that was issued in November 2018.
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FDA Ratchets Up Pressure on Homeopathic Drug Manufacturers

May 23, 2019 | Blog | By Benjamin Zegarelli

On May 14, FDA announced that it issued five Warning Letters to companies that manufacture and market homeopathic drugs for human use. The letters all cite cGMP deficiencies relating to inspectional observations and conclude that the products are misbranded prescription drugs under the Federal Food, Drug, and Cosmetic Act because “in light of their toxicity or other potentiality for harmful effect, or the method of their use, or the collateral measures necessary to their use, they are not safe for use except under the supervision of a practitioner licensed by law to administer such drugs” and they are not labeled for prescription use only.

In 2019 so far, FDA has issued Warning Letters to eleven separate homeopathic drug manufacturers, including the five letters referenced above. All of the Warning Letters, except one, cite observations from inspections and focus on cGMP and quality violations at the manufacturing facilities, including contamination and varying amounts of active ingredients, that could lead to consumer harm.
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FCA Defendant Abandons Petition Before the Supreme Court

May 22, 2019 | | By Samantha Kingsbury, Brian Dunphy

This latest installment in our ongoing coverage of the Polukoff False Claims Act (FCA) qui tam case might be one of our last posts about the case. Last week, Intermountain Health Care, Inc. and IHC Health Services, Inc. d/b/a Intermountain Medical Center (Intermountain), one of the hospital defendants in this matter, which had previously filed a Petition for a Writ of Certiorari with the U.S. Supreme Court on issues relevant to this case (as we reported in February), filed an Unopposed Motion to Dismiss before the high court.
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Yesterday, May 8, 2019, the Centers for Medicaid & Medicaid Services (“CMS”) released its final rule requiring drug manufacturers to disclose a drug’s wholesale acquisition cost (“WAC”) in direct-to-consumer television advertisements. The rule, which will become final 60 days after the official publication of the rule (which will be tomorrow, May 10, 2019) was proposal last fall. CMS is largely adopting the rule as published last fall with minor technical changes for clarification
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FCA Relator and U.S. Weigh in on Defendants' Argument that the FCA is Unconstitutional

May 9, 2019 | Blog | By Samantha Kingsbury, Brian Dunphy

As part of our ongoing discussion of the Polukoff False Claims Act (FCA) qui tam case (involving allegations that certain heart procedures performed by a cardiologist, and billed for by two hospital defendants, were not medically necessary), we reported in February that some defendants filed a petition for a writ of certiorari with the United States Supreme Court. 
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MLS Weekly Preview: Congress Keeping its Focus on Drug Costs

April 8, 2019 | Blog | By Alexander Hecht

This week, Congress will continue to look at lowering health costs. The House has been focused on both drug costs and overall health care costs, advancing packages to strengthen the individual market in addition to a series of bipartisan drug pricing bills. We cover this and more in this week's preview.
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CMS’s New Part D Policies Address the Opioid Epidemic

April 3, 2019 | Blog | By Daryl Berke

In recent months, we’ve highlighted several changes that CMS is implementing to combat opioid misuse. In this post, we focus on CMS’s new Medicare Part D Opioid Overutilization Policies.


Last year, CMS published a road map outlining the agency’s approach to addressing the nation’s opioid epidemic. CMS’s strategy has three prongs: (1) prevent new cases of opioid use disorder (OUD); (2) expand treatment for individuals with OUDs; and (3) leverage data to improve the agency’s prevention and treatment options.


In line with that strategy, the agency published an article detailing its Medicare Part D Opioid Overutilization Policies for 2019. The policies focus on improving communication between and among Part D plans (PDPs) and providers to better coordinate efforts to prevent opioid misuse. As CMS points out, “Providers are in the best position to identify and manage potential opioid overutilization in the Medicare Part D population. Medicare prescription drug plans can assist providers by alerting them about unusual utilization patterns in prescription claims.”
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The Supreme Court denied a petition for certiorari last Monday in U.S. ex rel. Prather v. Brookdale Senior Living Communities, Inc., No. 17-5826 (6th Cir. June 11, 2018), again declining to revisit or clarify the False Claims Act's “materiality” standard set forth in its 2016 decision in Universal Health Services v. United States ex rel. Escobar, 136 S. Ct. 1989 (2016). 

In Prather, the relator alleged that defendant Brookdale Senior Living Communities, Inc. (Brookdale), a home health provider, submitted bills for medical services that were “untimely” signed and certified by physicians in violation of Medicare regulations.  When submitting Medicare claims, Brookdale purportedly did not obtain the required physician certifications attesting that the medical services provided by Brookdale were necessary until months after establishing a patient’s plan of care.  Because Medicare regulations under 42 C.F.R. § 424.22(a)(2) require physician certifications “at the time the plan of care is established or as soon thereafter as possible,” the relator alleged that Brookdale’s untimely certifications rendered the claims false under the implied false certification theory.  The district court dismissed the complaint on materiality grounds, holding that the noncompliance was insubstantial and that the relator failed to allege that the government had ever denied a claim based on a violation of the timing requirement under the Medicare regulations.
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Surprise Medical Bills Gain National Attention

March 21, 2019 | Blog | By Bridgette Keller

No one wants to be faced with a large, unexpected medical bill after receiving health care services. Unfortunately, patients often find themselves in this situation after seeking emergency treatment or transportation, undergoing a surgical procedure, or even the birth of a child. These “surprise medical bills” occur when the patient goes to a hospital or facility that is “in-network” with the patient’s health plan, but the physician providing the services is not and is considered “out-of-network” or “OON.” This issue found its way back to the national stage this week, with several important highlights.
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OIG Approves Free Post-Discharge Care Program

March 18, 2019 | Blog | By Ellen Janos

Earlier this month, the Department of Health and Human Services Office of the Inspector General (OIG) issued an advisory opinion (Advisory Opinion No. 19-03) (Opinion) concluding that a program consisting of free, in-home follow-up care to patients at a higher risk of admission or readmission (the Arrangement) was “low risk” under the civil monetary penalties prohibition on beneficiary inducement (the Beneficiary Inducement CMP). This comes as good news to hospitals and other providers who are focused on care coordination and value-based programs.
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Last week, a U.S. district court judge in the Southern District of Florida upheld a magistrate judge’s decision to dismiss False Claims Act (FCA) allegations against a compounding pharmacy, its private equity firm owner, and two individuals. DOJ filed its complaint in intervention last February against the pharmacy, Patient Care America (PCA); its private equity backer, Riordan Lewis & Haden, Inc.; and two individual executives. The government alleged that the parties engaged in an illegal kickback scheme that resulted in the submission of false claims to TRICARE for expensive compounded drugs. This case is reportedly the first in which the federal government intervened against a private equity firm owner.
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AltaMed Health Services (AltaMed) and California Physicians Services (doing business as Blue Shield of California (BSC)) recently received notice from their business associate, Sharecare Health Data Services (SHDS), of a hack of SHDS’s network that stores patients’ medical records.  The hacker was able to acquire and/or access patients’ protected health information (PHI) contained in the medical records kept by SHDS on behalf of AltaMed and BSC. The breach of AltaMed’s data was discovered on June 22, 2018, and the breach for BSC was discovered a few days later on June 26, 2018. Upon investigation, however, officials determined that both breaches went undetected for over a month and actually began on May 21, 2018.
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On February 26, 2019, the Senate Finance Committee heard testimony from top executives representing seven high-profile drug manufacturers.  This hearing was the second to examine drug pricing in America. The Committee’s questions to executives from Pfizer, Merck & Co., Johnson & Johnson, AbbVie, Bristol-Myers Squibb, Sanofi, and AstraZeneca were aimed at identifying why already-high drug prices continue to climb and what can be done to stop the trend. The hearing comes during a period of increasing pressure on pharmaceutical manufacturers and others in the drug supply chain to improve patient access to drugs, increase transparency in drug pricing, and stop the trend of significant price increases.  This type of high profile hearing just confirms that these pressures will continue, and as a number of proposals to address drug prices work their way through Congress and multiple federal agencies, the discussion around drug pricing reforms will undoubtedly continue.  Following on ML Strategies’ coverage of the Senate hearing, below are a handful of key takeaways from the hearing.
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March 2019: Where Are We Now With 340B?

March 1, 2019 | Blog | By Ellyn Sternfield

What might 2019 mean for the 340B program? This post addresses the on-going litigation over the OPPS Medicare payment reduction for 340B drugs, ceiling price validation, and state initiatives related to the 340B program.
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On Tuesday, executives from seven of the largest pharmaceutical companies testified before the Senate Finance Committee on rising prescription drug prices. While the hearing was expected to be packed with fireworks as Senators of both parties grilled the nation's top pharmaceutical executives, it was largely uneventful.
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CMS Continues to Combat the Opioid Epidemic

February 21, 2019 | Blog | By Bridgette Keller

Last month, we highlighted a few of the changes CMS proposes in Parts I and II of the Advance Notice and Draft Call Letter. Here, we take a look at CMS’s next steps to combat opioid misuse. CMS is rolling out several new initiatives in this space this year and next.
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Independent Laboratory Settles Medical Necessity Allegations

February 20, 2019 | Blog | By Karen Lovitch, Cassandra Paolillo

The Department of Justice (DOJ) recently announced a $1.99 million False Claims Act (FCA) settlement with GenomeDx Biosciences Corp. (“GenomeDx”), a laboratory headquartered in Vancouver, British Columbia with operations in San Diego. The matter arose as the result of a qui tam case brought by two former employees in September 2017.
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Mintz Health Care Qui Tam Update - February 2019

February 20, 2019 | Article | By Hope Foster, Kevin McGinty, Randy Jones, Jane Haviland, Yarazel Mejorado

Read about health care qui tam litigation trends for the 12 months that ended on January 31 and significant cases, including two involving the issue of medical necessity.
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