In an ideal world, a healthcare ecosystem should provide transparent, ubiquitous, and secured access to individual’s health records, which can seamlessly transit between different healthcare providers resulting in better-coordinated care, competitive pricing, and an outcome-driven health ecosystem. This will result in minimizing care duplication (for example, laboratory tests) and promoting cost to deliver evidence-based care. The center of Medicare and Medicaid Services (CMS) is attempting to solve this problem through CMS Final Rule.
CMS Final Rule is based on the concepts of data interoperability. This is a critical aspect for the healthcare ecosystem since easy access to health records will always be of utmost importance. CMS in the past has promoted many data exchange mediums, including but not limited to standards like HITECH, EDI, HL7, and its variation. Over the years these standards have evolved resulting in the introduction of FHIR (Fast Healthcare Interoperability Resources). FHIR is a modern approach to health data interoperability that promises a standard error-free, easily readable data exchange API, adopted by different electronic health systems.
CMS Final Rule is evolving. Here are the published CMS Final rules:
- In May 2020, the first CMS Interoperability and Patient Access final rule was finalized. This final rule operates on the foundation of Medicare’s Blue Button initiative, which provides patient claims and clinical data to 85 million blue patients. Key Actors in this final rule are Payers and Patients.
- Around May 2020, ONC also finalized the 21st Century Cures Act final rule which will support patients’ access to their electronic medical records directly from healthcare providers through FHIR-standards-based APIs. Key Actors in this final rule are Providers and Patients.
- Come Jan 1st, 2023, CMS would mandate streamlining the Prior Authorization process (CMS-9115-F), enabling the electronic exchange of health data between the three most important parties – payers, providers and patients. This requirement is for Medicaid, CHIP managed care plans, state Medicaid, CHIP fee-for-service programs, and Qualified Health Plans.
Final Rule will also support the following by Jan 2022:
- Value-based programs, evidence and outcome-based payment
- Allow drug manufactures to report multiple best prices when offering their VBP arrangements to states.
- Allow states, payers, and drug manufacturers to enter into value-based purchasing agreements for prescription drugs, changing the 30-year-old Medicare Drug Rebate Program.
So, you may wonder why this is important? You may also think - it is just another CMS mandate, why should someone write an article on this topic? If your thoughts are sprawling in such directions, you are not alone. Ever since electronic data exchange is available, the ubiquitous sharing of data is a topic of discussion and debate. From FAX sheet to EDI messaging and the HL7 standards, the intentions from CMS remained more or less in the lines of sharing data faster, easier and cheaper. This time the new standard is FHIR, so being doubtful on what new will be achieved through this new data exchange resource is indeed a valid question. To decipher the excitement behind the CMS final rule we need to first understand a few important aspects
- First, why data exchange is important?
- How will the payer, provider and patient play out in the new ecosystem?
- How is FHIR different from other data exchange mediums?
- What is a Value-Based Program?
Criticality of breaking Data Silos
Areas such as the following, can only work when healthcare data silos are broken:
- administrative burden of data access and processing,
- driving clinical efficacies,
- clinical interventions before the disease becomes unmanageable, longitudinal studies,
- treatment measurement,
There are three aspects of promoting data availability:
Between players (providers, payers, patient) – seamless integration between the healthcare players will drive down administrative cost, minimize health record duplication (example retest because of lack of previous access to data), care coordination for better outcomes, and will provide health authorities a single pane of truth.
Health Tech Innovators’ Involvement – today’s technology advancement has enabled us to look at data like no other times. The computers can read petabytes of data in sub-seconds, interpret, analyze and report with definitive conclusions. The data sciences advancement based on statistical models allows us to predict future trends based on past data. Technology also enables reading data in motion and blend them with data at rest to draw real-time conclusions. Health data, which is currently siloed and segregated, if opened up because of the CMS Final rule, will drop the barriers and allow health tech innovators to leverage the data currency to improve care quality, remove human error, and significantly reduce costs.
CMS Mandate – as the value-based program becomes mainstream, CMS has to reward and penalize healthcare providers based on care outcome. Data will be the only way to authorize, approve and validate.
What is FHIR – why is it promising?
FHIR has evolved based on the learnings from the fallacies of its predecessor HL7. It stands for Fast Healthcare Interoperability Resources which enables data exchange for health surveillance to be an easier and simplified process. An FHIR resource has three parts, a common definition, metadata, and a human-readable part.
The beauty of FHIR is encapsulation – healthcare players no longer need to send individual documents or evidence but can point to the right information where all records are structured and connected in a meaningful way. FHIR works like how the world wide web works, every shareable content is a resource, and the resource can be accessed like a unique URL, which can be accessed from any system, any source.
FHIR does have its own set of challenges mostly governed by version differences and incomplete implementation by EHR vendors. However, this can be eliminated by using common API services which can abstract the version differences between EHR vendors.
Value-based care is a shift from fee-for-service to outcome-based service, where providers are responsible for the quality of care. The value-based program empowers patients, and the effectiveness of a treatment plan determines how much the provider should be paid. This increases accountability and innovation in the care continuum process. For a value-based program to work in health systems, data becomes the universal truth across the players of the healthcare ecosystem. CMS’s Final Rule is promoting such behavior through the adoption of the FHIR standard.
CMS has provided implementation guidance for the CMS Final rule in the following areas:
- Patient Access API, Payers are required to provide claims, patient encounter data, clinical data (that payers maintain) through this API
- Provider Directory API, MA organizations, Medicaid FFS programs, CHIP FFS programs, Medicaid managed care plans, and CHIP managed care entities are required to make provider directory information available through this API
- Part D Medicare Advantage Plan should make formulary information available through the Patient Access API
- Prior Auth, Payers need to provide the provider-patient coverage information before the treatment decision is made
In summary, following are the benefits of the CMS Final Rule:
- The Patient Access Final Rule requires the payer to exchange data when a patient switches Payer or have multiple payers using FHIR API. This will immensely help in having access to patient data almost in an instantaneous manner, helping reduce time and access to the medical records, hence promoting cost-effective care.
- The Patient Access Final Rule will require the payer to send patient claims, encounter data and clinical data directly to providers’ EHRs, resulting in time and cost reduction for the patient while elevating care quality.
- Time Reduction and redundancy checks - The Patient Access Final Rule requires payers to let providers know in advance what documentations are required so that the administrative burden on the provider is reduced while increasing patient experience.
- New VBP arrangements will help access innovative treatment plans for patients at large. As a result, it is estimated that these new VBP approaches could save up to $228 million in federal and state dollars through the year 2025.
- Combat Opioid crisis, implemented through Drug Utilization Review (DUR) Programs. Data will help identify beneficiaries who are already receiving substance use disorder (SUD) treatment and impede the issuance of opioids to such an audience.
- Payers will be empowered to negotiate with drug manufacturers, and Center of Medicare and Medicaid services will have better access to cheaper Prescription medicine.
- It is estimated that these new final policies clarifying the definition of line extension drugs could produce savings of $2.3 billion through the year 2025 in the form of additional manufacturer rebates to states.
- Medicare Part D is expected to save beneficiaries 1.9B in premium costs over the next seven years.
- Allow Part D to substitute certain generic drugs formulary more quickly during a year.
- During COVID times access to the right data at the right time will be important for health surveillance and timely intervention. When properly implemented CMS Final rule will enable this.
Future of Final Rule
CMS Final rule once fully implemented will promote the digital custodian behavior across the healthcare value chain. While the technology will provide the breeding ground for innovation and drop barriers for the health technology companies to exploit analytics-based intervention, the adoption of the Final rule across the ecosystem is the key. This is where CMS has to spend the maximum amount of time. One way to do this is by promoting value-based care and penalizing the non-performers.