The Organ Procurement and Transplantation Network has requested public comment on issues under consideration for revision, including reviewing the 2021-2024 OPTN Strategic Plan, clarifying the Multi-Organ Allocation Policy, modifying the Deceased Donor Registration (DDR) Form, requiring notification of human leukocyte antigen (HLA) typing changes, revising general considerations in assessment for transplant candidacy, and updating Transplant Program key kersonnel training and experience requirements. Find details and commenting instructions at https://optn.transplant.hrsa.gov/news/public-comment-open-from-jan-21-through-mar-23-2021/.
The NKF/ASN Task Force on Reassessing the Inclusion of Race in Diagnosing Kidney Diseases has been collecting information and testimony about health care disparities for Black/African American, Hispanic/Latino, American Indian/ Alaska Native, Asian American, and Native Hawaiian/Other Pacific Islander people, and about kidney function measurement, patient safety/standardization, new or innovative approaches to kidney function measurement, and measurement or reporting that does not include race. They will hold a January 22, 2021 public forum for patients, family members, and other public stakeholders. Register at https://kidney.zoom.us/webinar/register/WN_vVdJli2uRJKIgi4zlc8hfw. Find more information at https://www.kidney.org/content/nkf-asn-task-force-reassessing-inclusion-race-diagnosing-kidney-diseases.
KDIGO is planning a May 2021 Controversies Conference on Home Dialysis, has published a Scope of Work or draft plan for the Conference, and has requested feedback on it by January 4, 2021. The Conference intends to cover issues related to home dialysis utilization, candidacy, eligibility, outcomes, strategies for increase, patient and carer experience, support mechanisms, and financial implications. Find more information and links to the Scope of Work and Feedback Form at https://kdigo.org/conferences/hd/.
KDIGO is planning a March 2021 Genetics in CKD Controversies Conference, has published a Scope of Work or draft plan for the Conference, and has requested feedback on it by December 21, 2020. The Conference intends to cover issues related to monogenic and complex kidney diseases, applying genetic findings in clinical medicine, and using genomics for defining and stratifying CKD. KDIGO has prepared three webinars to introduce the issues, on Genetics in Kidney Disease, in Glomerular Diseases, and in Hereditary Kidney Diseases. Find more information and links to the Scope of Work, Feedback Form, and webinars at https://kdigo.org/conferences/genetics-in-ckd/.
CMS has filed a Paperwork Reduction Act (PRA) Notice to solicit comments on a proposal to renew its approval to collect information on the application for Medicare coverage for new ESRD patients, and on the general application for Medicare coverage. No changes to the forms are contemplated, but the PRA requires periodic renewals. Comments are due by November 23, 2020. Find the Federal Register notice at https://www.federalregister.gov/documents/2020/09/24/2020-21095/agency-information-collection-activities-proposed-collection-comment-request.
AAKP is supporting a research initiative with Relavo, a medical device company aiming to make peritoneal dialysis safer and more accessible by reducing the risk of peritonitis, which hospitalizes 15% of PD patients annually. Relavo is a recent winner of the KidneyX Innovation Accelerator Phase 2: Redesign Dialysis Competition, and of the KidneyX Patient Innovator Challenge. AAKP and Relavo are seeking patients and caregivers with CCPD experience that are over 18, currently live in the US, and read/understand English, to participate in an online survey. The results will be used to ensure that a Relavo device, the PeritoneX, addresses what matters most to patients and caregivers. Learn more about PeritoneX, which disinfects CCPD tubing during treatment set-up, at https://relavomedical.com/. Find the survey at https://www.surveygizmo.com/s3/5787206/Relavo-Device-Survey.
Home Dialysis Central has published a new blog post on The Power of the Patient Voice that cites many examples of how influential the voices of patients have been in CMS policies and regulations, especially those around home dialysis. Find the post at https://homedialysis.org/news-and-research/blog/369-the-power-of-the-patient-voice. In it they mention the ESRD PPS Proposed Rule on Medicare coverage and regulations that CMS publishes every year, and that Home Dialyzors United will next month remind all dialysis patients of your right to comment, and how to do it. If you’d like to read ahead, find a link to the 2021 PPS Proposed Rule at https://nwrnbulletins.wordpress.com/2020/07/10/9-4-comments-due-re-proposed-changes-to-qip/.
CMS has presented for publication in the Federal Register a new proposed rule on changes to the ESRD PPS/QIP. Public Comment must be received by September 4, 2020. “In addition to the annual technical updates for the ESRD PPS, the proposed rule proposes the following:
- “An addition to the ESRD PPS base rate to include calcimimetics in the ESRD PPS bundled payment;
- “Changes to the eligibility criteria and determination process for the transitional add-on payment adjustment for new and innovative equipment and supplies (TPNIES);
- “The expansion of the TPNIES to include new and innovative capital-related assets that are home dialysis machines;
- “A change to the low-volume adjustment eligibility criteria and attestation requirement to account for the COVID-19 PHE;
- “An update to the ESRD PPS wage index to adopt the new OMB delineations with a transition period. …
- “The following updates to the ESRD QIP:
- “Scoring methodology changes to the UFR reporting measure;
- “Updates to the NHSN validation study.”
- “This proposed rule also provides information received from two manufacturers whose products, a dialyzer and a cartridge for a home dialysis machine, are being considered for TPNIES in CY 2021.”
The (slightly edited) quotations are from the ESRD PPS CY2021 Proposed Rule Fact Sheet (CMS-1732-P) at https://www.cms.gov/newsroom/fact-sheets/end-stage-renal-disease-esrd-prospective-payment-system-pps-calendar-year-cy-2021-proposed-rule-cms. Find the Federal Register entry, which is scheduled to be published on July 13, 2020, at https://www.federalregister.gov/documents/2020/07/13/2020-14671/medicare-program-end-stage-renal-disease-prospective-payment-system-payment-for-renal-dialysis.
The University of Michigan KECC is conducting an ESRD Patient Reported Outcomes Quality Initiative Project Patient Life Goals Study, and seeks dialysis patients at least 18 years old to answer a new Survey that asks about your individual life goals and your dialysis facility care team. Life goals are personal goals that you think are important to achieve, such as having the ability to go to work, go to school, travel, or spend time with family. The Study aims to improve the odds that your care team will consider your individual life goals in the treatment planning process. Find an introductory letter and the Survey at https://redcapproduction.umms.med.umich.edu/surveys/index.php?s=DT4N3P48AC. There’s an easy-to-miss check box at the bottom of this page, which you have to check before the Survey questions appear. The Survey doesn’t seem to specify an expiration date.
CMS has published an Interim Final Rule with Comment Period on the Flexibility changes in Medicare rules made on March 31, 2020. The Comment Period will expire June 1, 2020. For details and comment see Medicare and Medicaid Programs: Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency at https://www.regulations.gov/document?D=CMS-2020-0032-0013.