Department of Health and Human Services July 2019 – Federal Register Recent Federal Regulation Documents

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

In compliance with the requirement of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Administration for Children and Families (ACF) within the U.S. Department of Health and Human Services (HHS) seeks an update to the existing data collection for the Annual Survey of Refugees. The Annual Survey of Refugees is a yearly sample survey of refugee households entering the U.S. in the previous five fiscal years. The requested update is based upon results of a multi-year effort in instrument redesign and field testing. ACF estimates the proposed changes will increase response burden from 30 to 45 minutes per respondent.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

This proposed rule would reform the Medicare and Medicaid long-term care requirements that the Centers for Medicare & Medicaid Services has identified as unnecessary, obsolete, or excessively burdensome. This rule would increase the ability of health care professionals to apportion resources to improving resident care by eliminating or reducing requirements that impede quality care or that divert resources away from providing high quality care.

This proposed rule would update the home health prospective payment system (HH PPS) payment rates and wage index for CY 2020; implement the Patient-Driven Groupings Model (PDGM), a revised case-mix adjustment methodology, for home health services beginning on or after January 1, 2020. This proposed rule also implements a change in the unit of payment from 60-day episodes of care to 30-day periods of care, as required by section 51001 of the Bipartisan Budget Act of 2018, hereinafter referred to the ``BBA of 2018'', and proposes a 30-day payment amount for CY 2020. Additionally, this proposed rule proposes to: Modify the payment regulations pertaining to the content of the home health plan of care; allow physical therapy assistants to furnish maintenance therapy; and change the split percentage payment approach under the HH PPS. This proposed rule would also solicit comments on the wage index used to adjust home health payments and suggestions for possible updates and improvements to the geographic adjustment of home health payments. In addition, it proposes public reporting of certain performance data under the Home Health Value-Based Purchasing (HHVBP) Model. We are proposing to publicly report the Total Performance Score (TPS) and the TPS Percentile Ranking from the Performance Year 5 (CY 2020) Annual TPS and Payment Adjustment Report for each home health agency in the nine Model states that qualified for a payment adjustment for CY 2020. It also proposes changes with respect to the Home Health Quality Reporting Program to remove one measure, to adopt two new measures, modify an existing measure, adopt new standardized patient assessment data beginning with the CY 2022 HH QRP, codify the HH QRP policies in a new section, and to remove question 10 from all the HH Consumer Assessment of Healthcare Providers and Systems (CAHPS) surveys. Lastly, it would set forth routine updates to the home infusion therapy payment rates for CY 2020 and propose payment provisions for home infusion therapy services for CY 2021 and subsequent years.

The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

This notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.

The Office of Population Affairs (OPA) announces the award of a single-source grant in response to an unsolicited proposal from the University of Northern Colorado, Greely, Colorado. The proposal submitted was not solicited either formally or informally by any federal government official.

This proposed notice acknowledges the receipt of an application from The Joint Commission (TJC) for initial recognition as a national accrediting organization providing home infusion therapy (HIT) services that wish to participate in the Medicare program. The statute requires that within 60 days of receipt of an organization's complete application, the Centers for Medicare & Medicaid Services (CMS) publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection associated with the FDA ``Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims,'' which is intended to assist applicants in developing labeling for outcome claims for drugs that are indicated to treat hypertension.

The Food and Drug Administration (FDA, Agency, or we) has determined that MIOCHOL (acetylcholine chloride intraocular solution), 20 milligrams (mg)/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for acetylcholine chloride intraocular solution, 20 mg/vial, if all other legal and regulatory requirements are met.

The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) seeks approval to collect descriptive information for the Early Head Start Family and Child Experiences Survey 2020 (Baby FACES 2020).

The National Institute of Dental and Craniofacial Research (NIDCR) is drafting its Strategic Plan for Fiscal Years (FY) 2020-2025 to help guide the research it supports over the next six years. NIDCR 2030 established five priority areas and accompanying goals, which we're now using to organize the 2020-2025 Strategic Plan. Through this Request for Information, NIDCR invites researchers in academia and industry, health care professionals, patient advocates and health advocacy organizations, scientific or professional organizations, Federal agencies, and other interested members of the public to provide feedback on NIDCR's next strategic plan.

This proposed rule would remove the regulatory text that sets forth the current required process for states to document whether Medicaid payments in fee-for-service systems are sufficient to enlist enough providers to assure beneficiary access to covered care and services consistent with the Medicaid statute. States have raised concerns over the administrative burden associated with the current regulatory requirements. While we believe the process described in the current regulatory text is a valuable tool for states to use to demonstrate the sufficiency of provider payment rates, we believe mandating states to collect the specific information as described excessively constrains state freedom to administer the program in the manner that is best for the state and Medicaid beneficiaries in the state.