Department of Health and Human Services April 23, 2019 – Federal Register Recent Federal Regulation Documents
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Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability and Patient Access for Medicare Advantage Organization and Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans in the Federally-facilitated Exchanges and Health Care Providers; Supplement and Extension of Comment Period
This document extends the comment period for the proposed rule entitled ``Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability and Patient Access for Medicare Advantage Organization and Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans in the Federally-facilitated Exchanges and Health Care Providers'' that appeared in the March 4, 2019 Federal Register. The comment period for the proposed rule, which would end on May 3, 2019, is extended 30 days to June 3, 2019. We additionally note that based on public comments received on this proposed rule, we will adjust the effective dates of our policies to allow for adequate implementation timelines, as appropriate.
21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program
On March 4, 2019, the Department of Health and Human Services (HHS) published a proposed rule that would implement certain provisions of the 21st Century Cures Act, including conditions and maintenance of certification requirements for health information technology (health IT) developers under the ONC Health IT Certification Program (Program), the voluntary certification of health IT for use by pediatric health care providers, and reasonable and necessary activities that do not constitute information blocking. The comment period for the rule was scheduled to close on May 3, 2019. This document extends the comment period for the proposed rule by 30 days to June 3, 2019.
Best Pharmaceuticals for Children Act (BPCA) Priority List of Needs in Pediatric Therapeutics
The National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) hereby announces the renewal of the Best Pharmaceuticals for Children Act (BPCA) Program. The Best Pharmaceuticals for Children Act (BPCA) seeks to improve the level of information on the safe and effective use of pharmaceuticals used to treat children. The BPCA requires that the NIH identify the drugs of highest priority for study in pediatric populations, publish a list of drugs/needs in pediatric therapeutics, and fund studies in the prioritized areas. This notice will provide a brief summary of recent changes in the legislation, a brief update on the current progress of the BPCA Program and provide the current Priority List of Needs in Pediatric Therapeutics.
Submission for OMB Review; National and Tribal Evaluation of the 2nd Generation of the Health Profession Opportunity Grants (OMB #0970-0462)
The Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS) is proposing data collection activities as part of the Health Profession Opportunity Grants (HPOG) to Serve TANF Recipients and Other Low Income Individuals. ACF has developed a multi-pronged research and evaluation approach for the HPOG Program to better understand and assess the activities conducted and their results. Two rounds of HPOG grants have been awardedthe first in 2010 (HPOG 1.0) and the second in 2015 (HPOG 2.0). There are federal evaluations associated with each round of grants. HPOG grants provide funding to government agencies, community- based organizations, post-secondary educational institutions, and tribal-affiliated organizations to provide education and training services to Temporary Assistance for Needy Families (TANF) recipients and other low-income individuals, including tribal members. Under HPOG 2.0, ACF provided grants to five tribal-affiliated organizations and 27 non-tribal entities. OMB previously approved data collection under OMB Control Number 0970-0462 for the HPOG 2.0 National and Tribal Evaluation. The first submission, approved in August 2015, included baseline data collection instruments and the grant performance management system. A second submission, approved in June 2017, included additional data collection for the National Evaluation impact study, the National Evaluation descriptive study, and the Tribal Evaluation. A third submission for National Evaluation impact study data collection was approved in June 2018. The proposed data collection activities described in this Federal Register Notice will provide data for the impact, descriptive, and cost benefit studies of the 27 non-tribal grantees participating in the National Evaluation of HPOG 2.0.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Monitoring and Reporting System for the National Tobacco Control Program. This information collection is requested by CDC to monitor progress in the states and territories funded through two CDC cooperative agreements
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled National HIV Surveillance System (NHSS). This data collection is for continuation of the National HIV Surveillance System which provides the primary population-based data used to describe the epidemiology of HIV in the United States including adult/adolescent and pediatric HIV case reporting, case report evaluations and updates, laboratory updates, deduplication activities, investigation reporting and evaluation, cluster reporting, perinatal HIV exposure reporting, and annual reporting of the standards evaluation report.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on Aggregate Reports for Tuberculosis Program Evaluation. The goal of the study is to allow CDC to collect and monitor indicators for key program activities, such as finding tuberculosis infections in recent contacts of cases and in other high-risk persons likely to be infected and providing therapy for latent tuberculosis infection in an effort to eliminate Tuberculosis in the United States. CDC is requesting approval for 268 burden hours. This is an increase of 42 hour from the previously approved 226 hours.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Agency for Toxic Substances and Disease Registry (ATSDR), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Human health effects of drinking water exposures to per- and polyfluoroalkyl substances (PFAS): A multi-site cross-sectional study (The Multi-site Study).'' The purpose of this research is to use sound study methods to see if drinking water exposure to PFAS is related to health outcomes.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Survey of Engineered Nanomaterial Occupational Safety and Health Practices. The goal of this project is to assess the relevance and impact of NIOSH's contribution to guidelines and risk mitigation practices for safe handling of engineered nanomaterials in the workplace.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Extended Evaluation of the National Tobacco Prevention and Control Public Education Campaign.'' This information collection request will enable the Centers for Disease Control and Prevention (CDC) to continue to measure exposure and awareness of the Tips From Former Smokers[supreg] campaign (Tips[supreg]) and to evaluate its impact on campaign-targeted outcomes among smokers and nonsmokers in the United States.
Submission for OMB Review; State Access and Visitation Grant Application (OMB #0970-0482)
The Office of Child Support Enforcement is requesting a three- year extension of the application form titled, Child Access and Visitation Grant Application Form, expiration 8/31/2019. There are no changes requested to the form.
Medicare Program; FY 2020 Inpatient Psychiatric Facilities Prospective Payment System and Quality Reporting Updates for Fiscal Year Beginning October 1, 2019 (FY 2020)
This proposed rule would update the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPFs), which include psychiatric hospitals and excluded psychiatric units of an inpatient prospective payment system hospital or critical access hospital. Additionally, this proposed rule would revise and rebase the IPF market basket to reflect a 2016 base year and remove the IPF Prospective Payment System (PPS) 1-year lag of the wage index data. This proposed rule also solicits comments on the IPF wage index. Finally, this rule proposes updates to the Inpatient Psychiatric Facilities Quality Reporting Program. These changes would be effective for IPF discharges occurring during the fiscal year (FY) beginning October 1, 2019 through September 30, 2020 (FY 2020).
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