Department of Health and Human Services May 7, 2018 – Federal Register Recent Federal Regulation Documents

The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act, referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' HHS is soliciting comments on further delaying the effective date of the January 5, 2017, final rule that sets forth the calculation of the ceiling price and application of civil monetary penalties, and applies to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. HHS proposes to further delay the effective date of the final rule published in the Federal Register from July 1, 2018, to July 1, 2019. HHS proposes this action to allow a more deliberate process of considering alternative and supplemental regulatory provisions and to allow for sufficient time for additional rulemaking.

In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. HRSA published the 60-day notice on December 15, 2017, FR Doc. 2017-27013. HRSA received one comment. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S.

The National Heart, Lung, and Blood Institute (``NHLBI''), an institute of the National Institutes of Health; an agency within the Department of Health and Human Services, is contemplating the grant of an exclusive patent license to commercialize the invention(s) embodied in the intellectual property estate stated in the Summary Information section of this notice to Precision IBD, Inc., located in San Diego, California, and incorporated under the laws of Delaware.

The Food and Drug Administration (FDA) published in the Federal Register of January 26, 2018, a direct final rule to amend the general biologics regulations relating to time of inspection requirements and to also remove duties of inspector requirements. The comment period closed April 11, 2018. FDA is withdrawing the direct final rule because the Agency received significant adverse comment.

We are proposing to revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2019. Some of these proposed changes implement certain statutory provisions contained in the 21st Century Cures Act and the Bipartisan Budget Act of 2018, and other legislation. We also are proposing to make changes relating to Medicare graduate medical education (GME) affiliation agreements for new urban teaching hospitals. In addition, we are proposing to provide the market basket update that would apply to the rate[dash]of[dash]increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits for FY 2019. We are proposing to update the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) for FY 2019. In addition, we are proposing to establish new requirements or revise existing requirements for quality reporting by specific Medicare providers (acute care hospitals, PPS[dash]exempt cancer hospitals, and LTCHs). We also are proposing to establish new requirements or revise existing requirements for eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) participating in the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (now referred to as the Promoting Interoperability Programs). In addition, we are proposing changes to the requirements that apply to States operating Medicaid Promoting Interoperability Prrograms. We are proposing to update policies for the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition (HAC) Reduction Program. We also are proposing to make changes relating to the required supporting documentation for an acceptable Medicare cost report submission and the supporting information for physician certification and recertification of claims.