December 10, 2019
Joanne Chiedi, Acting Inspector General
Department of Health and Human Services
Cohen Building, 330 Independence Avenue, SW
Washington, DC 20201
Attention: OIG-0936-AA10-P, Room 5521
Dear Inspector General Chiedi:
Thank you for the opportunity to comment on proposed revisions to safe harbors under the anti-kickback statute and civil monetary penalty rules regarding beneficiary inducements for value-based arrangements (VBAs).
The National Committee for Quality Assurance (NCQA) strongly supports VBAs and believes these proposed revisions can help streamline and accelerate movement toward them. We support scaling what new safe harbors allow to the degree of VBA’s financial risk, with the greatest protection for full financial risk. This is appropriate as greater risk increasingly ameliorates kickback and inducement concerns in traditional fee-for-service that generated current regulations.
We thank you for citing Patient-Centered Medical Homes (PCMH) as an effective VBA model for coordination and managing care with lower level risks. NCQA’s PCMH program is the nation’s largest and research shows that PCMHs improve quality, patients’ experience and staff satisfaction, all while reducing costs. Practices that earn recognition make a commitment to continuous quality improvement and a patient-centered approach to care.
The proposed requirements to allow safe harbors only if VBAs include an evidence-based outcome measure, assess progress yearly and terminate arrangements that harm quality or do not improve outcomes is important to ensure that arrangements drive improvement.
The proposal to let providers in VBAs offer patients in-kind supports to promote engagement in care and adherence to protocols is particularly important. Regarding your request for comment on whether to list specific tools you would allow, we believe you should not, as that could inhibit innovation that is robust and essential for VBAs. However, you should allow cost-sharing waivers and shared savings with patients to encourage use of high-value providers, such as PCMHs and Patient-Centered Specialty Practices, and less costly treatment options.
Regarding your request for comment on whether to limit VBA target populations to chronic conditions or disease states, we believe you should not, as many VBAs target broad populations.
However, you should let payers participate in selecting target populations or measures as payers often have a key role in identifying target populations and measures and providing valuable feedback to VBAs. Also, you should absolutely favor VBAs that align populations, measures and incentives with payers as this helps harmonize VBAs across programs and payers to reduce burden on clinicians and other providers.
You should not require VBAs to be evidence-based, as many VBAs are currently pilots or demonstrations intended to develop evidence on their efficacy. 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 potential financial benefits of questionable self-referral and their waivers warrant close monitoring.
You also should exclude VBAs that block data sharing, as data sharing is essential for the kind of care coordination effective VBAs require. Data sharing also is pivotal for moving to digital quality measurement that mines needed data from electronic health records, health information exchanges, registries and other sources to reduce burden, improve accuracy and measure more of 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 firstname.lastname@example.org.
Margaret E. O’Kane