The Daily Scan

September 13, 2018

Last Updated: 8:55 AM EST

Private Sector

  • Yesterday, Apple introduced the Apple Watch Series 4, redesigned and re-engineered to help users stay connected, be more active and manage their health in powerful new ways. Apple Watch Series 4 with watchOS 5 brings advanced activity and communications features, along with revolutionary health capabilities, including a new accelerometer and gyroscope, which are able to detect hard falls, and an electrical heart rate sensor that can take an electrocardiogram (ECG) using the new ECG app, which has been granted a De Novo classification by the FDA. (Apple.com)

 

  • Yesterday, global health service company Cigna announced the launch of Cigna Ventures, a corporate venture fund focused on transformative and innovative health care companies. Cigna has committed $250 million of capital to Cigna Ventures to invest in promising startups and growth-stage companies that are unlocking new growth possibilities in health care and will bring improved care quality, affordability, choice, and greater simplicity to customers and clients. Cigna Ventures is focused on companies across three strategic areas: insights and analytics; digital health and retail; and care delivery/management. “Cigna’s commitment to improving the health, well-being and sense of security of the people we serve is at the front and center of everything we do,” said Tom Richards, senior vice president and global lead, strategy and business development at Cigna. “The venture fund will enable us to drive innovation beyond our existing core business operations, and incubate new ideas, opportunities and relationships that have the potential for long-term business growth and to help our customers.” (Cigna.com)

Regulation

  • The U.S. Food and Drug Administration announced a series of critical and historic enforcement actions yesterday related to the sale and marketing of e-cigarettes to kids. In the largest coordinated enforcement effort in the FDA’s history, the agency issued more than 1,300 warning letters and civil money penalty complaints (fines) to retailers who illegally sold JUUL and other e-cigarette products to minors during a nationwide, undercover blitz of brick-and-mortar and online stores this summer. As a result of these violations of the law – and other indications that e-cigarette use among youth has hit epidemic proportions – FDA Commissioner Scott Gottlieb, M.D., signaled that the agency intends to take new and significant steps to address this challenge in a speech at the agency’s headquarters: “We’re committed to the comprehensive approach to address addiction to nicotine that we announced last year. But at the same time, we see clear signs that youth use of electronic cigarettes has reached an epidemic proportion, and we must adjust certain aspects of our comprehensive strategy to stem this clear and present danger." (FDA.gov)  

 

  • In conjunction with the announcement of the Apple Watch Series 4 yesterday, FDA Commissioner Scott Gottlieb, M.D., and Center for Devices and Radiological Health Director Jeff Shuren, M.D., J.D., released a statement on agency efforts to work with tech industry to spur innovation in digital health: "With these advances has come a new swath of companies that are investing in these new opportunities. These firms may be new to health care products and may not be accustomed to navigating the regulatory landscape that has traditionally surrounded these areas. A great example is the announcement of two mobile medical apps designed by Apple to work on the Apple Watch. One app creates an electrocardiogram, similar to traditional electrocardiograms, to detect the presence of atrial fibrillation and regular heart rhythm, while the other app analyzes pulse rate data to identify irregular heart rhythms suggestive of atrial fibrillation and notify the user. The FDA worked closely with the company as they developed and tested these software products, which may help millions of users identify health concerns more quickly. Health care products on ubiquitous devices, like smart watches, may help users seek treatment earlier and will truly empower them with more information about their health." (FDA.gov)

Medicare & Medicaid

  • Yesterday the Centers for Medicare & Medicaid Services (CMS) announced a new, more streamlined way for consumers to claim a hardship exemption from the tax penalty imposed for not maintaining health coverage for 2018 on their federal income tax returns, making it easier for taxpayers across the nation to claim their exemption. The official statement asserts: "Of the $3 billion the Internal Revenue Service (IRS) collected from taxpayers in individual mandate penalties in 2015, over 5 million households, or nearly 80 percent, earned $50,000 a year or less. The individual mandate penalty is yet another example of how the ACA hurts low and middle income Americans the most, and today’s action reflects our commitment to minimize the impact of Obamacare’s failures." (CMS.gov)

Litigation

  • Dr. Atif Babar Malik of Germantown, Maryland was sentenced this week to eight years in prison, followed by three years of supervised release. The sentence was imposed for his trial conviction on 26 counts arising from two criminal schemes involving $1.376 million in kickbacks and fraudulently billing, as well as his guilty plea to a conspiracy to defraud the United States of more than $2.1 million in taxes. According to evidence presented at trial, from January 2010 through the summer of 2012, APMS/ASC fraudulently submitted bills to Medicare and private insurers using a billing code that represented that two separate physicians had provided the nerve block and the anesthesia, when in fact, only one physician performed both.  As a result of this fraudulent “upcoding,” APMS/ASC received a higher level of reimbursement from insurers.  For example, on January 3, 2012, Dr. Sherlekar provided both spinal injections and anesthesia to a large number of patients at APMS/ASC’s Frederick office. However, he texted Dr. Malik that “I am using your name today as surgeon as we have 34 procedures here [in Frederick] and 20 in Waldorf,” to which Malik responded “ok.” Malik was seeing patients at his office in Hackettstown, New Jersey that day. (Justice.gov

 

  • Maria Mascio, a pharmacist from Columbus, Ohio, was sentenced in U.S. District Court this week to 24 months in prison and ordered to pay $1.1 million in restitution for executing a decade-long health care fraud scheme. Mascio owned an office building in which her pharmacy and the medical offices of two doctors were located. Mascio directed pharmacy employees to remove prescription drug samples from the medical offices and place them in a storage room used by the pharmacy. After collecting the drug samples, Mascio or employees under her direction removed the drugs from their individualized packaging and stored them in plastic bins. They disposed of the sample packaging in the dumpster located on the premises of the pharmacy and placed the sample drugs into the pharmacy inventory where they were co-mingled with the pharmacy’s stocked drugs and dispensed to the general public. Mascio also orchestrated the submission of false claims for the sample drugs to health care benefit programs, including Medicare, Ohio Medicaid and Ohio Bureau of Workers’ Compensation. (Justice.gov)

 

 

 

 

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