Interconnected: Digital Health Spans Key Issues From Counterfeit Medicines to Opioid Epidemic

You cannot tune into the news today without hearing about health care issues. Daily headlines on rising costs, declining insurance options, the opioid epidemic and the threat of counterfeit medicines flood inboxes and airwaves. In interesting ways, many of these issues are interconnected under the broad umbrella of digital health as advances in technology give rise to a new paradigm for how we access health care. Following are some examples of this interconnectedness:

• Consumers are increasingly looking online for cheaper versions of medicine due to rising drug costs. Indeed, the Alliance for Safe Online Pharmacies – Global recently reported that 44 percent of Americans look to the internet to purchase less expensive medications even though 88 percent of Americans feel they do not have enough information about counterfeits.
• Online sales of prescription opioids — whether for legitimate or illicit use — also continue to be a problem, as evidenced by a December 2015 publication in the Journal for Medical Internet Research. In a two-week period in 2015, more than 45,000 tweets were posted that directly promoted the illicit use of prescription opioids through providing a link to an illegal online drug seller.
• With out-of-pocket expenses for Medicare and Medicaid beneficiaries on the rise and an expected 49.5 percent growth in the U.S. senior population by 2030, older and more tech-savvy consumers are increasingly looking to the internet for cost-savings on prescription medications.

Not surprisingly, significant policy efforts are underway to address these interconnected issues, including:

1. Introduction of Telehealth Legislation: In an effort to expand health care access for Medicare beneficiaries, reduce costs and promote quality, policymakers have increased efforts to include telehealth and telemedicine provisions into proposed legislation. Recent examples include:
   • The CONNECT for Health Act (S.2484), introduced by Sen. Brian Schatz (D-HI) on February 2, 2016;
   • ACO Improvement Act of 2016 (H.R.6101), introduced by Rep. Diane Black (R-TN) on September 21, 2016;
   • Craig Thomas Rural Hospital and Provider Equity Act of 2016 (S.3435), introduced by Sen. Pat Roberts (R-KS) on September 28, 2016; and
   • The Expanding Capacity for Health Outcomes (ECHO) Act (S.2873), introduced by Sens. Orrin Hatch (R-UT) and Brian Schatz (D-HI) on April 28, 2016.
   On November 29, 2016, the Senate voted 97-0 in favor of the ECHO Act, which would require the Department of Health and Human Services to study technology-enabled learning and related models to be used in improving patient care and provider education, especially for those in rural areas.
   
   These bills, the flurry of state activity on telehealth and the increase in private sector investment in these activities evidences that digital health is taking hold and is here to stay. FaegreBD Consulting remains on top of these issues and will provide further updates as issues develop.


2. Addressing Internet Drug Sales: As patients look to the internet for answers and solutions to all sorts of medical needs, safeguards must be in place for patients. The Alliance for Safe Online Pharmacies – Global (ASOP Global, safeonlinerx.com), a nonprofit organization working with FaegreBD Consulting Principal Libby Baney, is collaborating with policymakers and partners to make the internet safer for patients around the world. Most recently, ASOP Global hosted an October 2016 international symposium in Beijing to discuss its recent report on the Chinese internet pharmacy market, share best practices and advance policy with Chinese government officials, NGOs, internet commerce companies and health care organizations. The Symposium is especially timely given recent reports of fentanyl and other derivatives from China entering the U.S. by way of online drug sellers and loopholes in the postal service.


3. Combatting Illicit Fentanyl: A new coalition, Americans for Securing All Packages (ASAP), was launched in September to help address vulnerabilities in postal service that allow counterfeit and otherwise illegal medicines into the U.S. without advanced screening precautions. By not requiring advance electronic shipping data for international packages, approximately 340 million packages enter the U.S. every year via the U.S. Postal Service without advance security screenings. In a July 2016 Intelligence Brief, the Drug Enforcement Administration notes the influx of non-prescription fentanyl — and other non-scheduled derivatives and analogues of fentanyl — into the U.S., often through the U.S. Postal Service and cut into street drugs, injuring or killing dozens in California, West Virginia and Florida.
   
   On September 7, 2016, Senator Rob Portman (R-OH) introduced the Synthetic Trafficking and Overdose Prevention (STOP) Act of 2016 (S.3292), which aims at closing the loopholes that allow foreign fentanyl to enter the U.S. unobstructed. With the support of Senators Ron Johnson and Kelly Ayotte, Portman hopes to bring the U.S. Postal Service level with the efforts of private shippers, who submit 98 percent of all customs declarations to the U.S. Customs and Border Protection, on average. Halting the unregulated shipping of illicit, counterfeit or otherwise dangerous medications to U.S. consumers by illegal online drug sellers and other bad actors will benefit public health, especially in the midst of the prescription drug abuse epidemic.


4. Collaborating on the Opioid Epidemic: The issue of illicit fentanyl and other synthetic opioids entering the U.S. through the postal service has been noted as contributing factors to the prescription drug abuse epidemic by the Collaborative for Effective Prescription Opioid Policies (www.cepoponline.org). Co-founded by the Honorable Mary Bono, a FaegreBD Consulting principal, CEPOP is a group of 72 organizations spanning the stakeholder continuum that develops and advocates for a comprehensive policy agenda to address the epidemic. To date, the focus of the Congressional response has been focused on the prevention, treatment and recovery of opioid use disorder; see: Comprehensive Addiction and Recovery Act of 2016 (PL 114-198). CEPOP takes a multifaceted approach to addressing issues, including safe use and prevention measures, takeback and anti-diversion practices, and the role of appropriate pain management in the inpatient setting. To this end, CEPOP recently convened partners in the fight against the prescription opioid abuse epidemic to host a national webinar. With keynote remarks from CMS’s Center for Clinical Standards and Quality Director Dr. Kate Goodrich, the program highlighted the best practices of specific Hospital Engagement Networks – including the Michigan Health and Hospital Association Keystone Foundation and the Hospital and Health System Association of Pennsylvania – in reducing adverse events from using opioids while appropriately managing acute pain in the inpatient setting. A recording of the webinar can be found at “Collaborative for Effective Prescription Opioid Policies.”