CMS Publishes Corrected Comment Deadline for FY 2016 IPPS and LTCH Proposed Rule; Comments Due by June 16, 2015 – On May 5, 2015, CMS published in the Federal Register a corrected comment period for the FY 2016 Medicare IPPS and LTCH Proposed Rule. CMS’s correction notice states that the comment submission deadline is June 16, 2015, not June 29, 2015, as was originally published. CMS’s correction notice is available here.
White House Initiates Review of 340B Drug Pricing Program Omnibus Guidelines – The Health Resources and Services Administration (HRSA) submitted guidance on the 340B Drug Pricing Program to the Office of Management and Budget (OMB) last week for review. OMB’s website reflects that the proposed rule was received on May 6. The document is expected to address key policy issues raised by the various stakeholders committed to the integrity of the 340B Program. For additional information regarding the anticipated scope of the proposed omnibus guidance, please see our February 16, 2015 Health Headline, available by clicking here.
Final ACO Regulations Under Review at White House – Last week, CMS sent the final rule for Accountable Care Organizations (ACOs) operating under the Medicare Shared Savings Program (MSSP) to OMB for review. The OMB’s website reflects that the proposed rule was received on May 5. CMS previously published a proposed rule in December 2014 that made several recommendations to improve flexibility for ACOs participating in the MSSP, including (1) additional options for ACOs renewing their participation in the MSSP; (2) the introduction of an additional risk sharing model; and (3) a greater emphasis on primary care. Additional information regarding the proposed rule is available in our December 8, 2014 Health Headline by clicking here.
HHS Establishes Organ Donation Policy for HIV-Positive Patients – On May 8, 2015, HHS released a final rule removing the current regulatory prohibitions against the transplantation of organs from individuals infected with human immunodeficiency virus (HIV). The final rule implements the changes to the National Organ Transplant Act of 1984 mandated by the 2013 HIV Organ Policy Equity (HOPE) Act. Under the final rule, organs from patients infected with HIV may be transplanted only into individuals who are already infected and who are participating in clinical research approved by an institutional review board under forthcoming research criteria to be published by HHS. The final rule is effective June 8, 2015. A copy of the final rule is available here.
King & Spalding Video Available Online from Health Law and Policy Forum Provider-Based Status Session – King & Spalding is pleased to be able to offer an individual session from its Health Law and Policy Forum by video covering The Road Ahead: The Future of Provider-Based Status. A link to the video and session written materials will be available for download here until July 1. Because the Health Law and Policy Forum has a registration fee, the registration fee for the video replay session will be $29.00.
