FDA: Avoid Powdered Pure Caffeine

Powdered caffeine, which is commonly sold over the internet and in other locations should be avoided, according to a Food and Drug Administration (FDA) release. Using ever stronger language, the FDA said the individuals with pre-existing heart conditions should not use the products. The FDA states that these products are almost 100 percent caffeine and even small amounts can be lethal. The FDA stated that it is aware of the death of a teenager in Ohio who consumed one of these products.

Dosage Amounts

The FDA said that consumption of a very small amount of these products can cause an accidental overdose. A single teaspoon of pure caffeine can be the equivalent of 25 cups of coffee. Furthermore, the FDA said that it is nearly impossible to accurately measure powdered caffeine with common kitchen tools. The Washington Post reported in a story on the death of an Ohio teenager that “a mere 1/16th of a teaspoon can contain 200 milligrams of caffeine, roughly the equivalent of two large cups of coffee.”

Symptoms

The symptoms of caffeine overdose include rapid or dangerously erratic heartbeat, seizures, vomiting, stupor, disorientation, and death, according to the FDA. The severity of these symptoms is much greater than simply drinking too much coffee, tea or other caffeinated beverage, said the FDA. An individual who believes they have consumed too much caffeine and are experiencing one of these reactions should seek immediate medical care.

Death of Teenager

A county coroner in Ohio ordered additional tests after a bag with white powder was discovered in the home of an Ohio teenager who unexpectedly died of seizures and an abnormal heart beat. Those tests revealed that the teenager had taken more than a teaspoon of the powder, or about 16 times the recommended dose, according to a report on Cleveland.com. The Washington Post article stated that the same corner’s report said that the teenager “had more than 70 micrograms of caffeine per milliliter of blood in his system, as much as 23 times the amount found in a typical coffee or soda drinker.”

The Substance Abuse and Mental Health Service (SAMHSA) reported that the number of emergency department visits associated with the use of energy drinks has doubled; going from 10,678 in 2007 to 20,783 in 2011. SAMHSA described energy drinks as flavored beverages containing high doses of caffeine. Caffeinated powder, which the FDA is advising people not to use and the cause of the death of the teenager in Ohio, is sold as a dietary supplement and as such is not as heavily regulated as other substances. Users routinely added it to drinks as a way of weight control.

The FDA would like people to report adverse events associated with the use of powdered caffeine by calling them at 240-402-2405 or by email at CAERS@cfsan.fda.gov.

FedEx Indicted for Distributing Illegal Internet Pharmacy Drugs

The U.S. Attorney for the Northern District of California has indicted the FedEx Corporation, FedExExpress, Inc. and FedEx Corporate Services, Inc. (collectively, FedEx) for conspiring with two separate—but related— online Internet pharmacy organizations, the Chhabra-Smoley Organization and Superior Drugs, to distribute controlled substances and prescription drugs to U.S. consumers who had no legitimate medical need for them based on invalid prescriptions.

Background

Since 1998, when Internet pharmacies first began offering consumers prescription drugs, some of these pharmacies have been filling orders based only on the completion of an online questionnaire, without a physical examination, a proper diagnosis, or a face-to-face meeting with a physician. This practice violates both federal and state laws governing the distribution of prescription drugs and controlled substances.

Warnings Made to FedEx

According to the indictment, as early as 2004, FedEx had been warned by the FDA, the Drug Enforcement Administration (DEA), and Congressional members and their staff that illegal Internet pharmacies where using FedEx services to distribute prescription drugs and controlled substances in violation of the FDC Act, the Controlled Substances Act (CSA), and other state laws.

Knowledge of Illegality Alleged

The indictment also alleges that in response to these warnings, FedEx established an Online Pharmacy Credit Policy requiring that all online pharmacy shippers be approved by the Credit Department prior to opening a new account. FedEx purportedly established a Sales policy in which all online pharmacies were assigned to a “catchall” classification to protect the commission-based compensation of its sales professionals from the volatility caused by online pharmacies moving shipping locations often to avoid DEA detection.

The indictment further alleges that, as early as 2004, FedEx clearly knew that it was delivering drugs to dealers and addicts because FedEx’s couriers expressed safety concerns to management that FedEx trucks were stopped on the road by online pharmacy customers demanding drugs, that the delivery address was a parking lot, school, or vacant home, and that FedEx drivers were threatened if they insisted on delivering packages to an address instead of giving the packages to individuals who demanded them. In response, the indictment alleges that FedEx merely held Internet pharmacy packages for problem shippers for pick up at specific stations, rather than delivering them.

FedEx’s employees are also alleged to have known that the Chhabra-Smoley and Superior Drugs online pharmacies had been shut down, and that their owners, operators, pharmacists, and doctors had been indicted, arrested, and convicted of illegally distributing drugs. Nevertheless, FedEx allegedly continued to deliver controlled substances and prescription drugs for these organizations.

Specific Statutory Violations

The indictment specifically charges FedEx with knowingly and intentionally conspiring with the Chhabra-Smoley Organization (from 2000 through 2008) and Superior Drugs (from 2002 through 2010) to violate the CSA, 21 U.S.C. Secs. 841 and 846, and the FDC Act, 21 U.S.C. Secs. 331, et seq., by distributing controlled substances and prescription drugs, including Phendimetrazine (Schedule III); Ambien, Phentermine, Diazepam, and Alprazolam (Schedule IV), to customers who had no legitimate medical need for them based on invalid prescriptions.

FedEx must appear in federal court in San Francisco on July 29, 2014, to answer the charges.

Mobile Health Apps Bridge Doctor-Patient Divide

Among the top-rated iPhone and Android apps, according to healthline.com, are programs that allow users to track the distance they walked or biked for the day, keep a personalized log of prescription drugs and relevant medical information, record recurring symptoms, and even monitor their sleep cycles, so a programmed alarm clock will go off when the users are at their lightest sleep period and ready to be awakened. Recent reports have indicated that these apps are not just being used by consumers, but are also being touted by physicians as tools used in patient treatment. As the “convergence of medical and consumer apps” becomes more apparent, newer, more highly-functioning apps are expected, yet, will those apps overload our collective hard drive and prove to be more hassle than helpful?

Convergence

A techonomy.com article explored the notion of the converging paths of medical and consumer health apps, stating that recent reports have shown that, “in the future, experts see the integration of consumer apps and devices into ‘a comprehensive healthcare and wellness information system,’ that could enable medical professional to help patients manage their health…” Specifically, the piece mentions the use of mobile apps at the cardiac rehabilitation program at the Mayo Clinic of evidence that, as one expert stated, “physicians are embracing the trend.” Additionally, four large app-building projects are underway at the Center for Digital Health Innovation at the University of California, San Francisco that would, if turned into products, be available to consumers to collaborate with physicians on health issues.

Recipe for Disaster?

While some are optimistic about the future of professional- and consumer-based usage of apps, others have raised questions about the future mobile app industry’s propensity for unwieldiness. In particular, an expert opined that the massive amounts and breadth of data that could be collected by these apps could present a regulatory nightmare while another claimed that “too much data could stifle physician productivity.”

On the Horizon

Regardless of the potential issues raised by the merging of mobile apps for consumers and physicians, it appears that innovation is already pointing in that direction, as one analysis finds that health care management apps are following in the footsteps of (and working in conjunction with) wearable fitness tracking devices. The report acknowledges certain apps that are “worth a look” including: Samsung S Health, which allows the consumer to track nutrition, fitness, and wellness; WebMD Healthy Target, which was designed as a tool for diabetics, hypoglycemic individuals, and those struggling with obesity to monitor weight and blood sugar; and Apple Health, which “displays personal biometric data- heart rate, calories consumers and burned, blood sugar and cholesterol – from the fitness apps that actually collect the data and from devices such as JawBone and IBGStar Blood Glucose Meter.”

An article published on the online Business Insider, however, states that while the new innovations in health care apps are popular, they are not necessarily effective. That source refers to a 2013 report issued by the IMS Institute for Healthcare Informatics that found “most consumer-oriented health apps are severely lacking when it comes to functionality or what they actually allow users to do.” Indeed, “…increased usage doesn’t necessarily correlate with quality.” Specifically, the author of this piece points out that while these health care supporting apps are plentiful, their functionality is limited. In turn, the source predicts, the real revolution is not in the convergence of consumer and medical professional usage of health apps but in the merging of wearable trackers that also function, as apps do, to compile and analyze tracked data. “The real killer app probably won’t be an app at all. It will be whatever device successfully combines the limited functionality that so many apps have into an integrated platform that can actually change people’s health and habits in a holistic way.”

This proposition begs the question, will these combined function devices take over the health care app game? If so, will these devices face similar regulatory and data administration and use challenges that health care apps potentially face? Regardless of the direction of this industry, the bridge between patient care by medical professionals, consumerism, and technology has been forged and consideration of its implications must be undertaken in order to cross it.

Kusserow’s Corner: House Hearing on Medicare Fraud and Abuse

The U.S. House Energy and Commerce Subcommittee on Oversight and Investigations held a hearing on “Medicare Program Integrity: Screening Out Errors, Fraud, and Abuse.” During the hearing, subcommittee members heard testimony from CMS Deputy Administrator and Director of the Center for Program Integrity Dr. Shantanu Agrawal, HHS Office of Inspector General (OIG) Deputy Inspector General for Investigations Gary Cantrell, and Government Accountability Office (GAO) Director of Health Care Kathleen M. King.

CMS Testimony

The CMS testimony revolved around how it is applying three operational principles to guide all of its initiatives: (1) aiming to achieve operational excellence in addressing the full spectrum of integrity causes, in taking swift administrative actions, and in the performance of audits, investigations and payment oversight; (2) providing leadership and coordination in program integrity efforts across the health care system; and (3) focusing on impacting the cost and appropriateness of care across health care programs. Some of CMS’s efforts to reduce fraud, waste and abuse were noted, including: (1) strengthening provider enrollment; (2) ensuring proper and accurate claims payment; (3) facilitating leadership and coordination across the health care system; and (4) improving payment data transparency.

CMS acknowledged the failure to meet its target goal of a reduced improper payment rate for Medicare fee-for-service, and that the improper payment rate had actually worsened over the last fiscal year. CMS noted that it recovered about $19.2 billion in fraudulent payments over the past five years, including $210 million through a new system that uses analytics to probe billing patterns; however, the recovered sum is dwarfed by the size of the problem, projected to be up to $50 billion a year.

The subcommittee cited one news outlet that reported that several doctors who had lost a medical license were still able to bill the Medicare program for millions of dollars. In addition, it noted that at least 14 individuals convicted of FDA-related crimes and debarred by the FDA do not appear to be excluded from the Medicare program; six doctors debarred by the FDA were paid over $1 million in Medicare payments in 2012. Another issue raised in the hearing was that a Medicare card has the patient’s social security number (SSN), creating serious risk of identity theft. Both the GAO and OIG identified fixing this SSN issue as an important step in preventing Medicare fraud.

GAO Testimony

The GAO testimony spoke to their strategies to combat fraud through examining: (1) the ability of CMS’ information system to prevent and detect enrollment of ineligible or fraudulent Medicare providers and suppliers; (2) the possible use of electronic-card technologies; (3) the oversight of program integrity efforts for prescription drugs; and (4) the oversight of certain contractors who conduct post-payment claims reviews. The GAO has focused on the following strategies: (1) provider and supplier enrollment; (2) prepayment and post payment claims review; and (3) addressing identified vulnerabilities. Based upon its work, the GAO recommended:

  • Requiring additional provider and supplier disclosures of information;
  • Establishing core elements for provider and supplier compliance programs as authorized in the Patient Protection and Affordable Care Act (ACA);
  • Increasing use of prepayment edits to help prevent improper payments;
  • Improving oversight of the information systems analysts use to identify claims for post payment, as well as the contractors responsible for the reviews;
  • Implementing mechanisms to resolve vulnerabilities that could cause improper payments; and
  • Removing SSNs from beneficiaries’ Medicare cards to help prevent identify theft.

OIG Testimony

The OIG testimony provided an overview of current health care fraud trends and challenges that impede effective oversight, as well as recommendations on how to address such trends and challenges that could result in billions of dollars being saved, along with a more efficient and effective programs. These included:

  • Providing the OIG with authority to execute federal warrants for the seizure of assets for forfeiture to curb the profitability of healthcare fraud, which will exert a deterrent effect.
  • Removing SSNs from Medicare cards to help protect the personally identifiable information of Medicare beneficiaries.
  • Strengthening the Medicare contractor’s monitoring of pharmacies and its ability to identify for further review of pharmacies with questionable billing patterns.
  • Requiring Part D plans to verify that prescribers have the authority to prescribe.
  • Increasing monitoring of Medicare claims for home health services.
  • Creating a standardized form to ensure better compliance with the face-to-face encounter documentation requirements for home health agencies (HHAs).
  • Implementing the surety bond requirement for HHAs.
  • Monitor hospices that depend heavily on nursing facility residents.
  • Modifying the hospice payment system for care in nursing facilities, seeking statutory authority if necessary.
  • Taking action to provide States with data for identifying overpayments for physician certification statement (PCS) claims when beneficiaries are receiving institutional care paid for by Medicare or Medicaid.
  • Mandating the use of the audit log feature in all electronic health records (EHRs).
  • Working with contractors to identify best practices and develop guidance and tools for detecting fraud associated with EHRs, with specific guidance to address documentation and electronic signatures in EHRs.
  • Amending regulations to require Medicare Advantage and Part D plans to report to CMS, or its designee, their identification of and response to incidents of potential fraud and abuse.
  • Establishing a deadline for when complete, accurate, and timely Transformed Medical Statistical Information System (T-MSIS) data will be available.

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

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Copyright © 2014 Strategic Management Services, LLC. Published with permission.