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Preparing for Three Federal Mandates to Improve Healthcare in 2021


Here are three key government mandates taking effect in 2021 that physicians should be preparing for.

While COVID-19 is rightly consuming the attention of healthcare leaders, the Department of Health and Human Services (HHS) is continuing to drive policies that improve electronic clinical information sharing, mitigate fraud in the opioid crisis, and deliver price transparency for patients. As many practices and health systems start reopening and resuming operating their practices in a new normal, it’s important to prepare for these initiatives that will have a direct impact on your practice and your patients.

Now that we are more than half-way through 2020, there are three key HHS mandates taking effect in 2021 that you should be preparing for:

Information blocking

It’s more critical than ever to be able to quickly locate and access clinical records. In the best of times or during a global pandemic, unlocking safer, higher quality and lower cost healthcare is essential. That’s what interoperability is — and information blocking is not — all about.

While the industry has made significant strides towards clinical interoperability with frameworks like Carequality, the new rules and regulations will significantly enhance clinical and administrative information sharing for patients and will require every provider and payer organization to evaluate their core technologies and policies and procedures to ensure compliance.

The 21st Century Cures Act defines interoperability as the access, sharing and use of individual patient information and health data.Information blocking is anything that interferes with, prevents, or materially discourages access, exchange, or use of electronic health information (EHI). 

The ONC Cures Act Final Rule, released on March 9, 2020, gives patients, their providers, and their choice of third-party health apps access to clinical data via application programming interfaces (APIs). This rule targets healthcare providers, health information networks, and health IT developers of certified health IT. In the initial phase of the rule, these actors must be able to share data that corresponds to the data elements in the United States Core Data for Interoperability (USCDI). The USCDI is a standard set of data elements that are important for interoperable health data exchange, such as clinical notes, problems, allergies, and medications. The second phase of the rule is broader—all electronicprotected health information in the electronic health record must be accessible by and available to the patient.

The CMS Interoperability and Patient Access Final Rule, also released March 9, 2020, includes policies that impact CMS regulated organizations, such as payers, hospitals, and clinicians. The intent of the rule is to give patients, their payers, and their choice of third-party apps access to clinical and administrative data via APIs. For example, the rule states hospitals must send Admit Discharge Transfer (ADT) Events notifications to another healthcare facility or to another community provider or practitioner to improve care coordination. With this rule, CMS will also publicly report eligible clinicians, hospitals, and critical access hospitals that may be information blocking based on how they attested to certain Promoting Interoperability Program requirements.

Compliance with these two rules is required starting later in 2020, although some enforcement dates have been modified due to COVID-19. With the complexity of the rules and the many elements of the enforcement timeline, it is imperative to work with your administrators, compliance advisors, and technology vendors to ensure adequate preparation.

1. Electronic Prescriptions for Controlled Substances (EPCS)

As a comprehensive law to address the opioid crisis, the SUPPORT for Patients and Communities Act states that prescriptions for all controlled substances covered under Medicare Part D must be transmitted electronically beginning January 1, 2021 (with minor exceptions for hardships).

Electronic prescribing of controlled substances (EPCS) is a more secure method to prescribe schedule II-V controlled substances that can prevent fraud, doctor shopping, and diversion. EPCS requires identity proofing, two-factor authentication, and digital signature processes, making it nearly impossible to create fraudulent prescriptions.

Currently about 50% of prescribers nationwide are EPCS-enabled. More than half of all states now require e-prescribing for opioids, all controlled substances, or all prescriptions.

Beyond preventing opioid fraud and diversion, EPCS allows physicians to have a consistent workflow and save time for all prescribing by eliminating the need to print prescriptions and by supporting electronic renewal of opioid prescriptions.

While virtually all EHRs are enabled for EPCS, the SUPPORT Act mandates that each prescriber must be set up with identity proofing and two-factor authentication. Your EHR vendor can provide compatible options and implementation approaches

2. Prescription Price Transparency

CMS has many initiatives designed to improve their beneficiaries’ ability to understand and manage their personal healthcare costs. As part of this cost transparency theme, CMS has published its Medicare Advantage and Part D Drug Pricing Final Rule, requiring Medicare Part D sponsors to implement an electronic real-time benefit tool (RTBT) capable of integrating with at least one prescriber’s EHR. The rule states that payors must implement tools by January 1, 2021.

Today, prescription price transparency solutions within EHRs are an important tool to help patients get necessary medications at an affordable cost. Prescription price transparency tools provide prescribers with the patient’s actual out-of-pocket cost based on a patient’s plan, deductible, co-pay, and other factors all within 1-2 seconds during the prescribing process. The prescriber can also see lower cost alternatives and quickly change to a more economical therapy within the prescribing workflow. That cost is calculated using the same methods and patient information as when the patient arrives at the pharmacy to ensure accurate pricing and prevent surprises at the pharmacy. Providers benefit from RTBT tools too; in addition to strengthening the patient-provider relationship, there is less need for rework and calls from pharmacies when a patient cannot afford the prescribed medication.

While this particular rule is focused on payer requirements, the CMS rule continues to strengthen the importance of this tool as it emerges as a standard of care. A recent survey found that 94 percent of patients who reported not taking their prescribed medication said they would have taken a lower cost alternative if it had been suggested to them. Additionally, the survey also revealed that many patients are willing to make changes with how they interact with their doctor to have cost conversations. In fact, 27% said they’d make an appointment at an inconvenient time, 21% said they’d be willing to wait a few weeks for an appointment, and 20% said they’d be willing to switch to a new doctor if it meant being able to discuss prescription prices and lower-cost alternatives.

As of December 2019, 88 percent of U.S. prescribers are served by contracted EHRs for a real-time benefit tool option. To enable this feature, practices and health systems should talk to their EHR vendor today.

As COVID-19 changes how we live and work, the world is still moving.

The Federal government’s continued push towards improved interoperability, reduced opioid fraud and abuse, and enhanced price transparency will continue to have a meaningful impact on physician practices and health systems. With enforcement of these policies and effects of related market trends in 2021, now is the time to plan, budget, and be prepared for the new rules.

Update: On August 3, 2020, the CMS proposed pushing the Part D EPCS mandate out to January 1, 2022.

Andrew Mellin, MD, Chief Medical Information Officer at Surescripts.

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