Policy and Politics News

A DaVita HealthCare Partners subsidiary is under federal investigation for possible violation of the False Claims Act. RMS Lifeline Inc., which does business under the name Lifeline Vascular Access, has received a civil investigative demand from the Justice Department relating to two vascular access centers it operates in Florida. The department is conducting a False Claims Act investigation and is reviewing the medical necessity of angiograms performed on 10 patients, covering a period from Jan. 1, 2008 through the present, according to DaVita's Nov. 18 filing with the U.S. Securities and Exchange Commission.

U.S. regulations require biosimilars to be highly similar to their reference product and demonstrate no clinically meaningful differences in safety, purity, or potency. For bio­similars of erythropoiesis-stimulating agents (ESAs), this standard is challenging because structural differences are likely, and their effect on safety and efficacy cannot be predicted from analytical studies. Thus, clinical trials should com­ pare hemoglobin, dose, and immunogenicity endpoints.

Payment reform led to a decline in home hemodialysis patients in the United States, according to a study presented at the American Society of Nephrology's Kidney Week 2015.

Mortality rates among dialysis patients dropped significantly from 2007 to 2012, with corresponding drops in hospital admission rates, according to analyses presented at the American Society of Nephrology’s Kidney Week.

A month into the transition from ICD-9 physician practice codes to ICD-10, the Centers for Medicare & Medicaid Services reported that the process is moving along smoothly.

On Oct. 8, the Centers for Medicare & Medicaid Services released the second round of its dialysis facility star rating system, and most of the dialysis facilities rated in CMS' Dialysis Facility Compare Star Rating Program in January 2015 and again in October 2015 received the same star rating each time.

As part of the final rule released yesterday for the ESRD payment bundle, CMS released the final requirements for the ESRD Quality Incentive Program for 2016. The agency has added a new measure to the program for payment year 2019, while removing four measures from the program. CMS also finalized changes to certain administrative requirements and other programmatic policies.

The Centers for Medicare & Medicaid Services released the final rule yesterday for the ESRD payment bundle for dialysis facilities and the ESRD Quality Incentive Program for 2016. There were few changes from the proposed rule to the final rule, and despite a strong effort to encourage CMS to pay more for home hemodialysis training, the agency declined to take action.

The adoption of technology in health care has been unique. While other industries adopt new and developing technology out of the need for innovation and interest in new products, the majority of physicians have adopted technology into their medical practice because the payer-the U.S. government via Medicare-has required it.

A bipartisan group of U.S. Senators is urging the Federal Trade Commission to investigate possible illegal collusion by saline solution manufacturers. The U.S. has had a shortage of saline solution since 2013, and the Senators noted that the three companies that provide all of the saline solution in the U.S. — Baxter International, Hospira, and B.Braun—have failed to end the shortage, but have raised prices by 200 to 300%.