Six Under-the-Radar Trends You Should be Thinking About in 2021

By Pooja Babbrah, PBM Practice Lead

By Ken Kleinberg, Innovative Technologies Practice Lead

It’s safe to say that 2020 was a year of surprises, right up until the very end. Even in the waning days of the year, the federal government dropped several unexpected pieces of regulatory guidance. These undoubtedly will shape the healthcare landscape for 2021—beginning with the final rule on use of electronic prior authorization under Medicare Part D, which dropped on December 31, 2020 (Click here to read our comment letter on the proposed rule, which was released earlier in the month.) We will be reporting on these and other major trends and developments, including interoperability, as 2021 rolls on. Stay tuned.

That said, we don’t want other trends to get lost in the sound and the fury surrounding only federal rule drops. That’s why we wanted to start off with a handful of under-the-radar trends. We’re paying attention to them as 2021 begins and you should be thinking about them, too. Our six picks are as follows. 

1. Digitization of patient consents. Like most of healthcare, consents for patients are moving from paper to electronic. We will see this shift in 2021 take on heightened importance including: privacy; medical treatment; research, especially for clinical trials; and advanced care directives. There are many drivers.

For example, eConsents may facilitate enrollment and tracking of hundreds of thousands of patients in clinical trials for COVID-19 vaccines and treatments. The new federal interoperability rules (click here to learn more) will put more responsibility on patients for selecting whom they allow to access their data and under what circumstances. eConsents will be key and will be needed among a broad range of payers, providers and others involved inpatient care, such as caregivers and long-term care facilities. The industry’s shift to value-based care models and the growth of patient-centered medical homes will require greater patient involvement and more complex consents among payers, providers and care team members. eConsent also will be an issue in Advance Care Planning (ACP), which also is picking up steam as an industry focus in 2021.

• Opportunities: Opportunities abound for the creation of disruptive technologies and approaches, which could completely change the eConsent landscape. Apple Health is an example. Its ResearchKit provides open-source software to help researchers recruit and gather data from medical research participants more efficiently. There also are opportunities for application programming interfaces API) connected apps to handle eConsents—especially in the hands of consumers.
  
  Recognizing the importance of eConsent and Advance Care Planning, the Interoperability Institute (IOI), Point of Care Partners (POCP), and Object Management Group® (OMG®) is sponsoring a full-day virtual conference on February 24 to discuss the many dimensions, opportunities and challenges surrounding the topic. Guest presenters will represent care providers, payers, ACP service providers, technology vendors and healthcare consumers. The agenda will include a “Lightning Round” consisting of 5-minute presentations of case studies and solutions. [Click here to sign up.]
  
  
• Challenges: The eConsent landscape is evolving. Patients must be a more prominent part of it. Patients will need to be educated on what they are consenting to and how the consents work. eConsents must be consumer-friendly, both in terms of technology and how the “fine print” is presented. At the same time, there are many issues around the technologies and standards for eConsents (click here to read more as outlined in a recent blog).

2. Electronic consent management. Once consents get digitized, they still need to be managed. This is a broad-ranging issue, which also will be gaining traction in 2021. Stakeholder organizations that need to manage consent effectively include health systems, researchers, providers, electronic health record (EHR) vendors, health information exchanges (HIEs), health information networks (HINS), labs, pharmacies, and payers/health plans. Organizations do not necessarily have to have direct patient interaction to be concerned with consent, as is the case with many HIEs that are not patient facing. Patient consents will need to be managed across stakeholders and technology platforms.

• Opportunities: Effective and early consent management strategies and protocols could be a competitive differentiator and enhance the membership experience. The latter is one metric on which organizations may be graded in value-based care organizations. Blockchain technology may be leveraged as a way to manage consents, especially among large integrated delivery systems. There are opportunities for payers and vendors to develop consent management capabilities in the nascent area of behavioral health management.
• Challenges: The transition from paper to digital consent management processes will be complex. Payers and providers will have to grapple with issues in transitioning manual consent management systems among disconnected platforms. Many use cases are evolving concerning how data are used and exchanged and which ones requires what kinds of consents.  For example:

o   Many actors and technologies involved in accessing and sharing patient data, are outside the requirements of the Health Insurance Portability and Accountability Act (HIPAA). As a result, new regulations may be created to address these new health data uses. At a minimum, many stakeholders will need to create new data use and business associate agreements.

o   Identity management is another major challenge involved in consent management. There is no single way to identify any patient and digital identity proofing is an evolving area. Patient-centric and organization-centric digital credentials will be needed to address the patient matching issue, which also will be picking up steam as a trend for 2021. Identity management doesn’t stop with patients; there are many endpoints for providers, payers and vendors. Stakeholders will need to develop and integrate identity proofing and management protocols into their technologies.

o   Consent strategies and governance will be key to determining the mechanics and management of consents, including how they mesh with state or federal policies and how they meet various legal and ethical requirements—and how to handle possible repercussions if they don’t (e.g., lawsuits and loss of membership). Consent management also must be consumer friendly. For example, it must be easy for consumers to understand what they are consenting to as well as change or withdraw consents. Demographics, health literacy and language barriers must be taken into account.

It also will be a busy year among the states. Until recently, just a handful of states (led by New York) had an EPCS mandate.  Now, twelve states have some form of EPCS in effect. That includes six states- -Arizona, Iowa, North Carolina, Oklahoma, Rhode Island, and Florida -- whose mandates became effective the first of this year. Sixteen others have passed legislation mandating EPCS, but with effective dates ranging from July 1, 2020 through January 1, 2022. Some laws require EPCS for opioids alone; others mandate EPCS for some or all controlled substances.

In addition, the opioid crisis is still heated, although the focus on COVID-19 has pushed it off the front burner. Together, they should impact EPCS. According to recent research, the drastic increase in the prevalence of behavioral health conditions in the U.S. due to Covid-19 will drive an estimated $140 billion in additional healthcare costs by the end of 2021. A pre-pandemic study found that although people with mental illness make up just 16% of the U.S. population, they receive more than half of the 115 million opioid prescriptions dispensed annually. At the same time, other statistics show that drug overdose deaths continue to skyrocket. More than 81,000 people died from overdoses in the year ending in May 2020. In addition, suicides in the military, veteran, and civilian populations continue to rise.

• Opportunities: The biggest uptick in adoption is likely in specialties with many Medicare patients, such as oncology and pain management. Prescribers may need some help in complying with and understanding the various state EPCS requirements as they go live. Having EPCS available at the point of care will add to overall interoperability and mesh with other initiatives. An example is price transparency at the point of care, which will result in the prescribing of controlled substances that will be covered by insurance and reduce the possibility of abandoned prescriptions or noncompliant use of the medications.
  
  In addition, the industry is working to make easier to access states’ prescription drug monitoring programs (PDMPs) through incorporation into prescribers’ workflows. Most states require prescribers to check the PDMP before “writing” an electronic prescription for controlled substances. The National Council for Prescription Drug programs (NCPDP) has proposed a standards-based model to facilitate PDMP data exchange. HL7 has issued an implementation guide, which outlines how systems can access PDMP data for a patient from the state PDMP systems using the Fast Healthcare Interoperability Resources standard (FHIR).
  
• Challenges: The onerous onboarding requirements for EPCS as mandated by the Drug Enforcement Administration (DEA), remain a pain point. They may change slightly in response to the DEA’s recent Interim Final Rule with Request for Comment. [Click here to read POCP’s  response.] The comment period closed in June and the DEA’s decisions in response to the public input have not yet been released.]  As mentioned previously, EPCS regulation in the states is an evolving, inconsistent patchwork. Physicians and healthcare organizations — especially those in multi-state areas -- may find it challenging to comply with the various state mandates, which do not have uniform requirements or compliance dates.

  Prescribers also appear to have issues with the transition from paper to electronic controlled substances prescriptions. Contrary to popular belief, EPCS may not decrease the number of opioids prescribed by clinicians. In fact, one study found that EPCS was associated with a small rise in EPCS prescriptions. While more research is needed, policymakers, payers and prescribers will need to address the impacts of EPCS on utilization.

4. Health IT and the COVID-19 vaccine. To be sure, there’s a lot of noise surrounding the development and deployment of the COVID-19 vaccine. Drilling down, there are critical roles for health information technology (health IT).  The first is leveraging data in electronic health records (EHRs) to identify patients who are at risk and eligible for particular vaccines, and ensure they receive the necessary follow-up care and/or a second dose when required. State roll-out of vaccination programs is slow, inconsistent and plagued with problems. These include freezer failures for the vaccines that must be kept at super-cold temperatures, changing guidance as to who gets the vaccines, and lack of clarity and coordination with vaccination protocols among state agencies, hospitals and patients.

• Opportunities: Leveraging patient data from EHRs, artificial intelligence (AI) and blockchain technology may be useful in identifying and tracking patients who are candidates for a particular vaccine, as well as identifying patients who are high risk, including minorities. Health IT also could be leveraged to identify the many thousands of patients in clinical trials who received placebo doses and get them vaccinated. Electronic patient consents and consent management will come to play, as patients likely will get two doses of a particular vaccine.     
• Challenges: Getting technologies quickly in place to respond to the quickly changing COVID environment is a challenge for all stakeholders. There is no one technology or method for managing vaccines, the supply chain or distribution across the uneven healthcare system. While some of this may be addressed at the federal level through Project Warp-Speed, the issues will be magnified at the state and local levels. We believe that many organizations—including public health departments and particularly individual physicians—will be challenged to address identification of vaccine recipients, monitor the rate of inoculation, track doses and identify any potential adverse effects, especially in the long term.

5. Shared decision making. As healthcare continues its tectonic shifts from provider-centric to patient-centered care, Shared Decision-Making (SDM) will play a more prominent role in 2021.  It is among several ways of engaging patients and involving them in their care.  SDM has shown to reduce preventable hospital readmissions among cardiac patients by at least 19 percent, and can also decrease patient anxiety and healthcare costs. In addition, SDM can lead to a positive patient experience, which can be used as a quality measure in value-based care. This should make SDM an attractive tool for value-based care organizations going forward.

SDM is important on several levels. On a macro level, it is part of the movement toward patient-centered care and empowering patients. On a practical level, it can help patients, their families and the care team to weed through complex treatment options, determine the benefits and harms of each and find a path forward. The SDM process builds trust among patients, caregivers and the care team. Patients and their caregivers are more likely to adhere to customized treatment regimens from trusted providers as well as ones they understand and agree to.

• Opportunities: Health IT is central to the SDM process. It can provide the patient and care team with information on evidenced-based care options and demystify the treatment process. Health IT may be used to create decision aids for the patient to help select their treatments and record their preferences, as well as manage the necessary informed consents. Health IT also can be used to document the SDM encounter, which is important for treatment and reimbursement.
• Challenges:  Few plans specifically reimburse SDM (although it is unclear how at this early stage), which is a barrier to adoption. Much development and standards work needs to be done for SDM to live up to its promise and be widely rolled out in value-based care. One study noted that limited patient education, language barriers and cultural disparities must be overcome for SDM to succeed.

6. The expanding role of pharmacists.  The roles of pharmacists have been expanding long before the COVID-19 pandemic. Pharmacists have been coming out from behind the counter to administer vaccinations and other tests; more proactively advise patients; and become a valued member of the patient care team. The pandemic has heightened the need for pharmacists, especially as vaccinations are rolling out. Yet their roles in the future can build on the foundation that is in place.

• Opportunities. Beyond the opportunities created by the pandemic, the need for expanded pharmacy roles is growing. The move toward value-based care will enhance opportunities for pharmacists to expand their scope of practice and add value to the organization’s metrics, such as improved outcomes, reducing medication errors and preventing readmissions, and speeding time to therapy with a greater role in ePrior Authorizations. Changes in how care is being provided, such as through precision medicine and the evolving world of specialty medications, will increase the need for pharmacists’ specialized knowledge and create more opportunities for patient care, education and advocacy.
• Challenges. Pharmacists have been lobbying to attain the same status as providers, not only in terms of where they sit in the professional pecking order but also in terms of reimbursement.  While special exemptions have been issued to permit pharmacists to expand their scope of practice during the pandemic and get paid for it, these exemptions may not become permanent. Changes in licensure requirements may be needed post-COVID also may be needed to permanently allow for pharmacists’ participation in telepharmacy, whose services cross state lines, and multi-jurisdictional care arrangements.

Looking ahead. 2021 is shaping up to be a year with many opportunities in healthcare as well as a plethora of challenges. We’d be happy to discuss them with you and help position your organization to be successful in the year ahead.  Reach out to us at pooja.babbrah@pocp.com and ken.kleinberg@pocp.com.  Want to keep with the ever-changing regulatory landscape at the federal and state levels? Our Regulatory Resource Center (RRC) can help with a variety of subscription solutions. Please contact our team at regulatory@pocp.com.

In this issue:

1. Health IT Under a Biden Administration: Part of the Problem or Part of the Solution?
2. Pulling Back the Covers on Health Information Exchanges: Part 2 Where They are Going and Why
3. Six Under-the-Radar Trends You Should be Thinking About in 2021