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Proposed Guidance Document: Study Protocols That Use Real-world Data

Public Comments

Commenter Comment Information
Blake, Andy Title: Office Manager
Organization: John A. Webster D.C. Inc. DBA Roswell Health and Injury Center
Date: 01/20/2025
Comment:
Chiropractors are required to show subluxation in one of two ways. exam or x-ray. I feel if x-ray is listed as one of the way to show subluxations then it should be covered by Medicare. If Medicare says that an x-ray IS shown to show subluxation and is used in court to show subluxation, then I do not understand why it is not a covered service. (That is my personal feeling on this matter.) (Do you know how many times a Chiropractor not only finds subluxations and not only that they see broke

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Crandall, Susan Organization: First Call Home Health
Date: 01/17/2025
Comment:

With the increased number of aged and people on Medicare services and the strain that it is placing on health care, especially SNFs and other inpatient facilities post acute care, I am recommending that the following items be considered for reimbursement or payment:

  1. Bath/shower equipment
  2. Compression stockings
  3. Other safety equipment for home use, that are deemed necessary by a PT or OT, such has hospital beds and overlays.

This would allow patients to stay

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Dreyer, Nancy Organization: Dreyer Strategies LLC
Date: 02/13/2025
Comment:
With regard to section 15.3, multiple testing adjustments are not needed. The emphasis should be on estimation of effects and understanding the confidence intervals around those estimates, not simply the p-value. See this highly cited paper by Rothman KJ. No adjustments are needed for multiple comparisons. Epidemiology 1990;1:43-46
Robinson, Daniel Date: 02/10/2025
Comment:
My parents depend on Medicare. My Dad is a veteran who was in Vietnam. They depend on Medicare and social security to cover medical expenses in their golden years. If they had to pay out of pocket for [PHI Redacted], they could never afford it. The healthcare system is outrageously overpriced and this would be a death knell if they were cut off or reduced. The cost of all expenses these days is through the roof for basics, please do not touch Medicare and work on lowering

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Rose, Eric Title: Chief Medical Informatics Officer
Organization: Crecendo Health
Date: 02/20/2025
Comment:

First, the authors of the proposed guidance are to be commended for this thoughtfully written document, and their commitment to ensuring that use of real-world data conforms to sound scientific principles. The comments below are offered in the spirit of improving what is already a very strong start.

1. Re: Section 7, “Research Methods”
Tables 4-8 and 10 prompt for the source of any phenotyping algorithm(s) used to define time 0 criteria, inclusion criteria, exclusion criteria,

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Spychalska, Galia Title: RN, MS, FNP
Organization: Colorado Pediatric Health Advocates LLC
Date: 01/19/2025
Comment:

Discriminatory algorhythmic use of pathways by CMS with use of NCD and pathways based on data is biased against populations of people with rare and or genetic diseases or multiple disease conditions as there is not enough robust data to be able to show statistical significance in treatment plan or care …one size does not fit all would deny access to medically necessary health care services and products to this population of patients increasing the risk of harm and progressing those disease

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WHALEN, KELLY Title: U.S. CITIZEN
Date: 02/07/2025
Comment:

The Food and Drug Administration’s (FDA’s) decision to approve Aduhelm for treatment of Alzheimer’s disease showed a stunning disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

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