NCQA Comments on Proposed Stark Rule Changes

NCQA Supports changes to the Stark rule on physician self-referral for value-based payment arrangements.

December 10, 2019

Seema Verma, Administrator
Centers for Medicare & Medicaid Services
Department of Health & Human Services
7500 Security Blvd.
Baltimore, MD 21244-1850
Attention: CMS-1720-P

Dear Administrator Verma:

Thank you for the opportunity to comment on proposed exceptions to physician self-referral regulations for value-based payment arrangements (VBAs).

The National Committee for Quality Assurance (NCQA) strongly supports VBAs and believes these proposed exceptions can help streamline and accelerate movement toward them. We support offering three safe harbors and exceptions based on VBAs level of financial risk, with the greatest protection for full financial risk. This is appropriate as greater risk increasingly ameliorates self-referral concerns in traditional fee-for-service. The exceptions for full financial risk VBAs should, as proposed, require that remuneration is not an inducement to reduce or limit medically necessary items or services to any patient. However, full financial risk should apply only to services the VBA covers for its target population, not all Part A and B services as proposed, as some VBAs have limited scope.

We support the proposal to define VBAs’ required purpose to be eligible for proposed exceptions as either:

  1. Coordinating and managing the care of the target patient population;
  2. Improving the quality of care for the target patient population;
  3. Appropriately reducing costs or growth in expenditures without reducing quality; and
  4. Transitioning from health care delivery and payment mechanisms based on the volume of items and services provided to mechanisms based on the quality of care and control of costs of care for the target patient population.

We do not support the alternative proposal for number 3 above to require VBAs to have already shown improvement which they must maintain. That would inhibit new VBAs and slow the movement to them.

However, you should retain the right to subject each VBA to case-by-case review to guard against potential misuse and account for models that blend value based and FFS reimbursement. Bundled payment models, for example, continue to pose a gaming threat because providers could simply increase the number of bundles by delivering them to patients who may not need the services. For bundled models, the waiver should apply only to cases that meet consensus and evidence-based appropriateness criteria.
Similarly, one-sided risk models may lack sufficient value-based incentives to counteract the potential financial benefits of questionable self-referral and thus warrant close monitoring.

Requiring prospectively established objective, measurable quality standards is particularly important for determining whether and how much VBAs improve quality. This why HEDIS®, the most widely used and respected clinical quality metrics, has such broad use today. We appreciate that measurable quality standards may not apply to some VBAs, such as those providing only infrastructure supports. However, such examples are rate and all VBAs – regardless of their level of risk – should include quality measures unless they are able to explicitly demonstrate why they do not need them.

We strongly support the proposals to prohibit donors of interoperable electronic health records (EHRs) from any information blocking and to create a new exception allowing donation of cybersecurity technology. Health IT is vitally important in coordinating care in VBAs, which requires the free flow of information. Health IT also poses serious patient privacy risks for which cybersecurity is crucial. Data exchange and cybersecurity also are essential for digital quality measurement, which is a priority for CMS, NCQA and many other stakeholders. Digital measurement mines needed data from EHRs, health information exchanges, registries and other sources to reduce burden, improve accuracy and measure what matters. Improving burden and accuracy and measuring what matters also greatly benefits the development and evolution of VBAs.

Thank you again for the opportunity to comment on the proposals. If you have any questions, please contact NCQA Director of Federal Affairs Paul Cotton at (202) 955-5162 or


Margaret E. O’Kane

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