Haystack Responds to CMS’ National Provider Directory RFI

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See our full comments here

If CMS determines to develop the NDH, we ask that it do so in consultation with patient groups, including rare and ultra-rare disease advocacy organizations, so that the end product is useful, accessible, and efficient for patients and their caregivers. Haystack expects that the types of information that will be most helpful to patients includes, at a minimum:

  • Provider name and contact information, including all practice locations

  • Complete licensure information o This should include all states in which a provider is licensed regardless of physical location, as recent advances in telehealth allow providers to treat across state lines

  • All networks and plans to which a provider is enrolled (and their status, i.e., participating in a plan, “accepting” reimbursement as payment in full, out-of-network provider willing to submit claims, etc.) o This should include Medicare, Medicare Advantage, Medicaid fee for service (and states for which Medicaid is accepted), Medicaid managed care (including Medicaid plans in other states) and all private insurance

  • Provider specialties and sub-specialties

  • Years in practice

  • Hospital affiliation • Whether new patients are being accepted

  • Average wait time for both new and existing patient appointments

  • The availability of telehealth services

  • Languages spoken

Haystack Project's sign-on letter commenting to CMS' proposed NCA for monoclonal antibodies

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While the proposed NCA addresses new treatments for an all-too-common condition in Medicare beneficiaries, Haystack Project has serious concerns that it will, if finalized,

  • Represent an unprecedented challenge to the validity of the accelerated approval process that is integral to advancing new therapies in rare diseases

  • Perpetuate and exacerbate health inequities associated with race, ethnicity, and socioeconomic status - Impermissibly substitute CMS’ analysis of clinical evidence and conclusions for decisions delegated to and made by FDA, and

  • Raise significant ethical concerns by conditioning coverage for on-label use of the first FDA-approved treatment with potential to mitigate disease progression on participation in CMS-directed, randomized clinical trials.

The proposed NCA represents an unprecedented challenge to the validity of the accelerated approval process.

See the full comment letter here