Response to comments

CMS-576 and CMS-576A Responses to 60 Day Comments.09.12.23.docx

Organ Procurement Organization's Health Insurance Benefits Agreement and Supporting Regulations 42 CFR 486.301-486.348 (CMS-576 and CMS-576A)

Response to comments

OMB: 0938-0512

Document [docx]
Download: docx | pdf

PRA package for CMS 576 & CMS-576A forms

Response to Public Comments




  1. Comment # CMS-2023-0010-0003:

This commenter submitted 3 identical attachments consisting of the same questions and responses in each. There was an individual who provided the responses to the questions.


Each attachment contains the following text:

Questions for Commenters


The non-exhaustive list of questions below is meant to assist members of the public in

formulating comments and is not intended to restrict the feedback that members of the public

may provide:


  1. Do some Department information collections or processes place a more significant burden on certain types of respondents, particularly individuals and entities that could be more adversely affected? If so, what impact could this have on these respondents in accessing public benefits?


We don’t feel that any of the Department information collections or processes placed a more significant burden on a certain type of respondent.


  1. Do some Department information collection requests contain questions that the commenter might perceive as having limited value or utility? If so, please identify specific data elements when recommending burden reduction solutions.


We don’t feel that any questions have limited value or utility.


  1. Do some Department information collections request duplicative information? If so, please recommend solutions (for example, eliminating duplicative questions in a specific collection or consolidating multiple collections)?


In referring again to Section A of the Annual Reports, we felt that providing measures for goals and actual achievements in terms of a raw number, ratio, and percentage was a request for duplicate information.


  1. What data-linkage or data-sharing activities can the Department engage in to reduce the burden of information collections?


The only examples that we see duplicated on the PDP, Pre-Scholarship Agreements, and Exit Certificates is a request for the year a student enters the program and the date when a year of work has been completed and a request for the amount of Scholarship Funds Expended. Providing this information for these reports is not a burden.




  1. The Department recognizes that burden can be reduced by improving the usability of forms. How might the Department reduce burden by improving the usability of forms, independent of eliminating data collections or data elements?


A great improvement was made by introducing digital Pre-Scholarship Agreements and Exit Forms. Any other forms that scholars can complete would help reduce burden.


  1. What additional feedback would you like to share regarding challenges, barriers, or suggested improvements for obtaining benefits from the Department?


No additional feedback at this time.”


CMS Response to Comment # CMS-2023-0101-0003:


We thank this commenter for submitting their comment. We note that the questions and responses are not related to the contents of the PRA package.



  1. Comment # CMS-2023-0101-0004:


In their comment, this commenter stated the following:


Organ trafficking, a lucrative global illicit trade, is often a lesser discussed form of human trafficking among anti-human trafficking stakeholders due to its intricate and often stealth nature. Trafficking sex and/or labor are the more commonly thought of forms of human trafficking among public policy leaders and general awareness campaigns. However, organ trafficking holds a critical place with transnational organized crime groups due to high demand and relatively low rates of law enforcement.

Organ traffickers’ profit in the shadows, while their destructive medical footprint is the only thing that is felt. It leaves vulnerable populations, aka “donors,” and first world beneficiaries, aka “recipients,” open to severe exploitation and a lifetime of health consequences.

When describing organ trafficking, there is often confusion as to how this crime can happen. Global Financial Integrity (GFI) estimates that 10 percent of all organ transplants including lungs, heart and liver, are done via trafficked organs.1 However, the most prominent organs that are traded illicitly are kidneys, with the World Health Organization (WHO) estimating that 10,000 kidneys are traded on the black market worldwide annually, or more than one every hour.

On their own, these numbers can be stark; however, when compared to average wait times for organs in developed countries, one can start to better understand the demand being diverted to black markets. In Canada, it is estimated that the average wait time for a kidney is




4 years with some waiting as long as 7 years.3 In the U.S., the average wait time for a kidney is 3.6 years according to the National Kidney Foundation.4 In the U.K., wait times average 2 to 3 years but could be longer.

Once obtained, trafficked organs can be transplanted to recipients in the most reputable of hospitals in major cities throughout the world but makeshift operating rooms in houses have often been the clandestine locations for such transplants.

Traffickers orchestrate the recruitment of the donor often from a place of vulnerability, and victims are not necessarily properly screened for their qualifications to be a healthy donor. Desperate patients in need of an organ may fall prey to a trafficker who could be posing as a “reputable” representative of an altruistic organ matching organization. Financial exploitation plays a key part in both sides of this scenario. In addition, organ traffickers could also be involved in other forms of human trafficking, such as sex and/or labor trafficking. Cases are emerging where an organ donor may have been a victim of sex trafficking and/or labor trafficking as well as a victim of organ trafficking, creating a multi-level equation of exploitation. The term “transplant tourism” is often utilized in describing this crime, as defined by the Declaration of Istanbul:

“…travel for transplantation that involves organ trafficking and/or transplant commercialism or if the resources (organs, professionals and transplant centers) devoted to providing transplants to patients from outside a country undermine the country’s ability to provide transplant services for its own population.”

Building a strong border wall and boosting deportation and trafficking investigation efforts will ensure trafficked organs do not make it into the American marketplace.”


CMS Response to Comment # CMS-2023-0101-0004:


We thank the commenter for their comment. While this comment is not related to the issues discussed in the PRA package, CMS acknowledges that illicit organ trafficking is criminal in nature and a serious problem. CMS-approved Organ Procurement Organizations should have processes in place to ensure that the donated organs are obtained from legitimate sources.


3


File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorCAROLINE GALLAHER
File Modified0000-00-00
File Created2023-10-19

© 2024 OMB.report | Privacy Policy