PCORI Announces CER Grants

The Patient-Centered Outcomes Research Institute (PCORI) announced that up to $76 million in funding for comparative effectiveness research (CER) projects will be granted for opportunities related to: the assessment of prevention, diagnosis and treatment options; improving health-care systems; communication and dissemination research; addressing disparities; and accelerating patient-centered outcomes research and methodological research. Letters of intent for the grants are due by September 5th.

CMS Issues Final FY 2015 Medicare Payment Rules for Hospitals and Hospices

CMS issued final rules under which 3,400 general acute care hospitals and 435 long-term care hospitals will receive a 1.4% net increase in their fiscal year (FY) 2015 Medicare payment rates, although the agency said the rule will still reduce overall spending on inpatient hospital services by about $756 million in the fiscal year because of disproportionate share hospital (DSH) and other changes to inpatient prospective payment system (IPPS) payment policies. CMS also issued a final rule under which 3,545 hospice entities will receive a 1.4% net increase in their payment rates for the next fiscal year. The rule also requires hospices to provide CMS with a notice of election (NOE) within five days of a beneficiary’s election of exclusive medical services from a hospice and named attending physician.

CMS Announces Demo to Evaluate IVIG Home Infusion

CMS announced that applications are due between August 8 and September 12 for a new demonstration project designed to evaluate the benefits of providing bundled payments for Medicare Part B items and services needed for the in-home administration of intravenous immune globulin (IVIG) for eligible beneficiaries with a diagnosis of a primary immune deficiency disease (PIDD). The three-year demo may enroll up to 4,000 Medicare beneficiaries and spend up to $45 million.

Launch of Open Payments System Delayed

CMS announced that it will delay the public launch of the Open Payments System for an unspecified period in order to investigate technical issues with the website, such as long wait times and other errors, that physicians are having in trying to review and verify payment disclosure reports.

Republican Senators Urge the FDA to Release Guidance on Biosimilar Pathways

Senators Lamar Alexander (R-TN), Orrin Hatch (R-UT), Mike Enzi (R-WY), Richard Burr (R-NC) and Pat Roberts (R-KS) have written the Food and Drug Administration (FDA) urging the agency to “immediately release [draft] guidance pending within the HHS related to the implementation of the biosimilar pathway…..Only in this way will FDA’s policies be informed by patients, healthcare professionals, policy makers, and others.” They said that participation by interested parties is necessary before the FDA settles on final rules.

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