Updates by Reed Smith on U.S. legislative & regulatory developments affecting the health care industry
The Department of Health and Human Services (HHS) has released two proposed rules intended to increase the availability of organs for transplantation and improve the accountability of organ procurement organizations (OPOs), in conformance with President Trump’s Executive Order on Advancing American Kidney Health.
First, the Health Resources and Services Administration has proposed expanding the…
The Trump Administration has announced a number of policy goals and innovation models that seek to “improve the lives of Americans suffering from kidney disease, expand options for American patients, and reduce healthcare costs,” according to the Department of Health and Human Services (HHS). The broad policy framework was outlined in an executive order on…
On May 8, 2015, the Health Resources and Services Administration (HRSA) published a final rule to implement the HIV Organ Policy Equity Act (HOPE Act), which modifies standards related to Organ Procurement Transplantation Network (OPTN) acquisition of organs from individuals known to be infected with human immunodeficiency virus (HIV). Under the final rule, organs…
This post was written by Nancy Sheliga.
The OIG recently estimated that Medicare could have saved approximately $8.9 million if organ procurement organizations (OPOs) had correctly reported procurement of double lungs as two organs in their FY 2011 Medicare cost reports. The report cited reliance on CMS’s Provider Reimbursement Manual, which does not provide …
President Obama recently signed into law S. 330, the HIV Organ Policy Equity Act, which eliminates the restriction on acquiring HIV-positive organs in order to permit research on transplants involving HIV-positive individuals. In addition, the President has signed S. 252, the "Prematurity Research Expansion and Education for Mothers who deliver Infants Early Reauthorization…
On November 12, 2013, the House of Representatives approved S. 330, the HIV Organ Policy Equity Act, which would eliminate the restriction on acquiring HIV-positive organs in order to permit research on transplants involving HIV-positive individuals (the Senate approved the bill in June). The House also passed S. 252, the Prematurity Research Expansion…
On July 17, 2013, the House Energy and Commerce Committee approved H.R. 698, the HIV Organ Policy Equity Act. The legislation would eliminate the restriction on acquiring HIV-positive organs in order to permit research on transplants involving HIV-positive individuals. The Senate approved its version of the bill, S. 330, on June 17, 2013.
On March 20, 2013, the Senate Committee on Health, Education, Labor, and Pensions approved an amended version of S. 330, a bill to amend the Public Health Service Act to establish safeguards and standards of quality for research and transplantation of organs infected with human immunodeficiency virus (HIV). Among other things, the bill would…
