CMS ACCESS Model: Changing the Landscape of Disease Management

The Center for Medicare and Medicaid Innovation (CMMI) has been a key driver of value-based health care since its inception in 2010. ItsACCESS Model (Advancing Chronic Care with Effective Scalable Solutions) is a 10-year demonstration project CMMI launched this year. The program is discussed here because it has the potential to establish value-based changes that produce meaningful gains in patient outcomes, which should be highly constructive for biopharma.

The ACCESS Model’s significance for the industry is that it introduces a new level of operational capacity to what remains disease management at its core. If we think of disease management evolving over time:

• Disease management 1.0 centered on population identification, evidence-based clinical guidelines, patient education, self-management and routine monitoring.
• Disease management 2.0 added the use of predictive analytics, care coordination, provider risk-sharing and quality metrics.
• Disease management 3.0 could emerge from the ACCESS Model, adding a new layer that leverages digital tools in patient care and ties provider reimbursement to measurable outcomes.

Conditions targeted fall into four tracks: 1) early cardio-kidney-metabolic; 2) cardio-kidney-metabolic; 3) musculoskeletal; and 4) behavioral health.

While the program was conceived and developed for Medicare Part B beneficiaries, the CMMI notes, “Private payers representing 165 million members across Medicare Advantage, Medicaid and commercial coverage have also committed to aligning with the ACCESS Model’s payment approach, with many beginning this year.”

Key ACCESS model program features

Broadly, the program has three key components. The first creates participating ACCESS organizations designed to operate as“digital ecosystems.” These organizations use connected devices (eg, blood pressure cuffs, glucometers, wearables); telehealth platforms; digital apps; artificial intelligence-supported engagement software; plus care management staff to support primary care or other physicians in treating and monitoring patients.

Under the demonstration project, ACCESS organizations ship devices directly to the patient, activate the digital platform and provide onboarding/training. As a condition of participation, patients do not pay for the devices.

The technologies, which must all be FDA-approved, link physician and patient from a monitoring standpoint and ACCESS organization with the Centers for Medicare & Medicaid Services from an outcome-payment standpoint. Also, the program requires each organization to manage all conditions within a clinical track.

Second, primary care and other physicians are expected to refer interested patients to ACCESS organizations. Physicians retain full treatment responsibilities.

Given the consolidation in primary care, especially around hospital system-owned practices, it would not be surprising if these systems invest in the requisite digital technologies and care management staff to become ACCESS organizations as well. For those systems with an accountable care organization, integration in the latter should significantly strengthen their overall risk management capacity.

The third component centers on outcomes-based reimbursement. ACCESS organizations receive specific payments for managing qualifying conditions and earn the full amount when patients meet measurable targets such as lower blood pressure or reduced pain. Physicians receive their normal Medicare Part B visit fee plus a recurring care-coordination payment. Also, like the ACCESS organization, physicians receive additional payment linked to patients achieving their targeted outcome.

Implications for biopharma

The ACCESS Model has the potential to introduce an advanced level of disease management into health care delivery. For preferred formulary brands tied to the designated conditions, especially those not subject to generic step requirements, this represents a natural lever to increase and maintain market share.

For orphan products, the ACCESS Model is not a current focus. However, given an estimated 1 in 10 in the U.S. living with a rare condition, plus the heavy concentration of drug spend on small orphan populations, it is not unreasonable to assume private payers with their sizeable, self-insured customer base gradually supporting ACCESS organizations designed for these high-cost patients.

Nor is it unreasonable to anticipate that independent specialty pharmacies serving orphan populations and those owned by pharmacy benefit managers will each view ACCESS organizations as a future line extension for new revenue generation.

Every brand formulary situation that fits the ACCESS Model’s chronic condition priorities comes with its own business considerations brand managers should understand. There is also a business case for orphan product brand managers to understand the potential specialized ACCESS organizations might offer patients in the future and, perhaps more importantly, to influence how that future landscape will take shape.

Ira Studin, PhD, is president, Stellar Managed Care Consulting. He can be reached at istudin@stellarmc.com.