Marriage equality reduces the number of uninsured: JAMA study

A significant number of people in same-sex relationships gained employer-sponsored insurance (ESI) coverage as a result of the implementation of the New York Marriage Equality Act, according to an article published in the Journal of the American Medical Association (JAMA) on June 26, 2015. There also was a small reduction in the number of individuals on Medicaid. Based on these findings, the author anticipates that the Supreme Court decision in Obergefell v. Hodges mandating marriage equality will reduce the number of uninsured nationwide.

Methodology

The author, Gilbert Gonzales of the University of Minnesota School of Health, Division of Health Policy and Management, used data from the American Community Survey, an annual mail survey conducted by the U.S. Census Bureau. Same-sex couples were identified when the primary respondent to the survey indicated that his or her spouse or domestic partner was a person of the same sex. He compared the rate of ESI coverage among same-sex couples to that of opposite-sex married couples in New York from 2008 through 2010, before enactment of the statute, to coverage in 2012. New York began to issue marriage licenses to same sex-couples on July 24, 2011.

The respondent for each household identified the source of insurance coverage for each member of the household. The responses were sorted into Medicare, coverage through a current or former employer, TRICARE or other military health care, coverage purchased directly from the insurance company, Medicaid, and uninsured.

Insurance trends in general

Before enactment of the law, rates of coverage were dropping slowly for both groups. In 2012, there was a 6.3 percent increase in ESI among men in same-sex relationships, while Medicaid coverage dropped 2.2 percent. Among women in same-sex relationships, there was an 8.9 percent rise in ESI and a 3.9 percent drop in Medicaid enrollment. The trends in rates of ESI coverage among opposite-sex couples did not change.

Lollipop device helps the blind see with the tongue

The FDA has cleared for marketing the BrainPort V100, an investigational medical device that people who are blind may use with a white cane or guide dog to perceive the location, position, size, and shape of objects, and to determine whether objects are moving or stationary. The  BrainPort V100 was reviewed by the FDA through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk medical devices that are not substantially equivalent to an already legally-marketed device.

The battery-operated non-surgical device, manufactured by Wicab, Inc., of Middleton, Wisconsin, includes a video camera mounted on a pair of sunglasses that is connected to a small, flat lollipop-like device containing 400 electrodes that the user holds against the tongue. Software converts the image captured by the video camera into electrical signals that are sent to the lollipop device and felt as vibrations on the user’s tongue.

According to Wicab, the video camera works in a variety of lighting conditions and has an adjustable field of view. White pixels from the camera are felt on the tongue as strong stimulation, black pixels as no stimulation, and gray levels as medium levels of stimulation. Users of the device report the sensation as pictures that are painted on the tongue. A small hand-held unit about the size of a cell phone provides user controls and contains a rechargeable battery. With a minimum of 10 hours of supervised one-on-one training and experience, the user learns to interpret the signals to determine the location, position, size, and shape of objects, and to determine if objects are moving or stationary.

According to the FDA, the safety and effectiveness assessment of the BrainPort V100 included object recognition and word identification, as well as oral health exams to determine risks associated with holding the intra-oral device in the mouth. Clinical studies showed that 51 of the 74 subjects who completed one year of training were successful at the object recognition test. Some subjects reported burning, stinging or metallic taste associated with the intra-oral device. There were, however, no serious device-related adverse events reported.

Robert Beckman, CEO of Wicab, recently told Mobile World Live that he “is looking to mobile and wireless technologies to improve the company’s first-generation BrainPort V100 device.” Right now the device is not connected to the internet, explained Beckman. “[Through the use of wireless connections] we can eliminate the handheld controller and all the controls will be on the frame of the glasses, and we will wirelessly connect the device to mobile technology which will greatly expand the capabilities of the device.”

 

Michigan hospitals conspired to hide information from consumers

Four hospital systems in south-central Michigan had an unlawful marketing territory agreement that deprived consumers and physicians of important information about competing providers for years, according to the Department of Justice (DOJ), which filed a lawsuit against the hospital systems in the Eastern District of Michigan. “These hospitals conspired to deprive consumers and physicians of important health information and education,” said Assistant Attorney General Bill Baer of the DOJ’s Antitrust Division. “Instead of putting patients first, these hospitals secretly agreed not to compete.”

Unlawful agreement

Hospitals compete to attract patients by advertising, including the use of direct mailings to patients, outreach to physicians and employers, conducting health fairs, and offering free health screenings. According to the DOJ’s complaint, four hospitals—each the only hospital in its respective county—entered into agreements to limit the marketing of competing health care services. As a result, patients and physicians were deprived of information needed to make informed health care decisions, and some were prevented from receiving free medical services like health screenings and physician seminars that, in the absence of the unlawful agreements, they would have received.

The hospitals sued by the DOJ are:

  • Hillsdale Community Health Center (Hillsdale)—a Michigan corporation headquartered in Hillsdale, Michigan, with a general acute care hospital located in Hillsdale County, Michigan. Hillsdale has 47 beds and a medical staff of over 90 physicians.
  • Community Health Center of Branch County, Michigan (Branch)—a Michigan corporation headquartered in Coldwater, Michigan, with a general acute care hospital located in Branch County, Michigan. Branch has 87 beds and a medical staff of over 100 physicians.
  • ProMedica Health System Inc. (ProMedica)—an Ohio corporation headquartered in Toledo, Ohio, with locations in northwest Ohio and southern Michigan, including Bixby and Herrick Hospitals in Lenawee County, Michigan. Bixby is a general acute care hospital with 88 beds and a medical staff of over 120 physicians. Herrick is a general acute care hospital with 25 beds and a medical staff of over 75 physicians.
  • A. Foote Memorial Hospital, doing business as Allegiance Health (Allegiance)—a Michigan corporation headquartered in Jackson, Michigan, with a general acute care hospital located in Jackson County, Michigan. Allegiance has 480 beds and a medical staff of over 400 physicians.

The complaint alleges that Hillsdale curtailed competition for years by entering into agreements with Allegiance, Branch, and ProMedica to limit the marketing of competing health care services.

Settlement

Three of the hospital systems—Hillsdale, Branch, and ProMedica—agreed to settle the charges, while the DOJ will continue to litigate against Allegiance. The proposed settlement would prohibit the three systems from entering into agreements with other health care providers, including hospitals and physicians, to limit marketing or to divide any geographic market or territory. It also prohibits communications among the hospital systems about their marketing activities and requires them to implement compliance measures tailored to prevent the recurrence of these types of anticompetitive practices in the future.

The proposed settlement will be published in the Federal Register. Written comments may be submitted within 60 days of its publication.

Eleven charged in counterfeit energy drink conspiracy

The Department of Justice estimates that over four million bottles of counterfeit 5-Hour ENERGY® that were made with unregulated ingredients in an unsanitary facility were sold to distributors in the United States as part of a sophisticated, international counterfeiting conspiracy. The Department of Justice announced that 11 individuals were indicted for their part in the conspiracy and are facing charges for crimes relating to trafficking counterfeit goods, introducing misbranded food into interstate commerce, and criminal copyright infringement.

5-Hour ENERGY is a dietary supplement that is manufactured in Wabash, Indiana by a group of entities identified as Living Essentials,  LLC, which owns the trademarks and a copyright associated with the product line and does not provide any other entities licenses to manufacture the products.

Repackaging

According to the indictment, the conspiracy began after Joseph Shayota and Adriana Shayota entered into an agreement with Living Essentials to distribute 5-Hour ENERGY in Mexico through their company, Baja Exporting LLC.  The agreement provided that the drink was to be distributed solely in Baja, Mexico, and Living Essentials would manufacture the drink and provide labeling and display boxes that were printed in Spanish. The indictment alleges that the Shayotas tried to divert the products in order to sell them in the U.S. at a higher price than in Mexico. However, they were unsuccessful in selling the products because of the Spanish-language labels and display boxes. As a result, they allegedly made counterfeit 5-Hour ENERGY labels and repackaged the products in the fake labels. They are alleged to have sold over 350,000 of the repackaged drinks at a price that was 15 percent lower than the amount the product typically sells for in the U.S.

Counterfeiting

After the Shayotas had sold off all of the repackaged 5-Hour ENERGY drinks, they allegedly decided to manufacturer their own, fake version of the drink. The indictment alleged that, in early 2012, they used untrained workers to manufacture the drink in an unsanitary facility. The Shayotas’ manufacturing process included mixing unregulated ingredients in plastic vats. The indictment further alleges that they ordered seven million fake label sleeves and hundreds of thousands of fake display boxes and marked the bottles with fake lot and expiration codes that they periodically changed to mimic valid codes.  The Shayotas also allegedly hired manufacturers to produce blank plastic bottles and caps that were imprinted with the trademarked “Running Man” logo and purchased various equipment including a steam tunnel machine for shrink wrapping the fake labels.

Distribution

The product was allegedly distributed by Midwest Wholesale Distributors, which sold more than four million of the counterfeit drinks through various commercial channels. The Department of Justice released a partial list of retailers to whom the counterfeit energy drinks were sold. The list reveals that the drinks were sold to retailers across several states including, California, New York, and Michigan.

FDA Oversight

The FDA regulates dietary supplements such as 5-Hour ENERGY. The Food, Drug, and Cosmetic Act (FDC Act) (21 U.S.C. § 331) prohibits the introduction of adulterated or misbranded food, drugs, or cosmetics into interstate commerce. The Act casts a broad net of  liability, and the FDA warns that anyone who introduces adulterated or misbranded products into interstate commerce can be implicated, including manufacturers, distributors, and retailers.

According to Special Agent in Charge Lisa L. Malinowsk of the FDA’s Los Angeles Field Office of Criminal Investigations, regulation is important in protecting the safety of U.S. consumers. In a released statement she said, “Criminals who produce and sell counterfeit and misbranded dietary supplements put the public health at risk by utilizing unknown and unregulated ingredients that could put the consumer in danger of serious illness or death.  This alleged counterfeit operation was especially egregious as the investigation revealed this product was sold, distributed and placed on the shelves of numerous retailers throughout the United States.  We will continue to investigate violators of our laws and work to bring them to justice.”

According to the Living Essentials website, the counterfeit energy drinks were removed from store shelves years ago.