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Regulatory Review
May 10, 2021
UPDATED VACCINE TOOLKIT Last week, the Centers for Medicare & Medicaid Services (CMS) released an update to the Coverage and Reimbursement of COVID-19 Vaccines, Vaccine Administration, and Cost Sharing under Medicaid, Children’s Health Insurance Program
(CHIP), and Basic Health Program (BHP) vaccine toolkit. As part of the revised toolkit, CMS discusses: • The expansion of the mandatory benefit for vaccine and vaccine administration coverage to nearly all Medicaid
beneficiaries as required by the American Rescue Plan Act (ARP).
• The enhanced 100% federal match for COVID-19 vaccines and their administration as provided for in the ARP.
• The authorization of the Janssen (Johnson & Johnson) vaccine.
CMS intends to updated the toolkit in the future to reflect the Department of Health & Human Services (HHS) release of additional Public Readiness and Emergency Preparedness Act (PREP Act) declarations.
GUIDANCE ON NEW HOSPITAL ELECTRONIC PATIENT EVENT
NOTIFICATION REQUIREMENTS Today, CMS released guidance for providers and state surveyors outlining new requirements for admission, discharge, and transfer electronic patient event notifications. The Interoperability and Patient Access final rule, published May 1, 2020,
included revisions to the hospital Conditions of Participation (CoPs) that require hospitals that utilize an electronic medical records system or other electronic administrative system conformant with certain content exchange standards to send electronic patient event notifications of a patient’s admission, discharge, and/or transfer to applicable post-acute care services providers and suppliers or any practitioner(s) a patient considers primarily responsible for his or her care. CMS also
released FAQs on general interoperability topics, which includes information related to the event notification requirements.
NEW MIPS FACT SHEETS CMS recently posted the following two new resources to the Quality Payment Program (QPP) Resource Library:
• 2021 MIPS Group Participation Guide: This guide provides details on group eligibility and how to participate and
submit data as a group.
• 2021 MIPS Automatic Extreme and Uncontrollable Circumstances Policy Fact Sheet: This document provides
guidance for clinicians affected by natural disasters during 2021. Note that as of early May, CMS has NOT
designated COVID-19 as a basis for qualifying for this automatic MIPS exemption. However, clinicians may submit
an application for a 2021 exception due to COVID-19.
2 Highlighting indicates an item is new in this edition of the Regulatory Review Hart Health Strategies Inc. www.hhs.com
The Program Integrity Monitor
OIG Work Plan Updates The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) maintains a dynamic, web-
based Work Plan, which is updated on a monthly basis to ensure it more closely aligns with its planning process. All active Work Plan items can be found on the OIG web site. The web-based Work Plan will continue to evolve as OIG completes and adds new work items.
OIG Compliance Resource Portal OIG maintains a Compliance Resource Portal to assist public stakeholders looking for resources that can help ensure compliance with Federal health care laws. The portal includes links to toolkits, advisory opinions, special fraud alerts, and
dedicated pages with resources for various providers, including physicians and Accountable Care Organizations (ACOs).
The Innovation Landscape
Centers for Medicare and Medicaid Services (CMS)
Maryland Total Cost of Care Model – CMS last week posted information on the model website informing stakeholders that the Maryland Primary Care Program (MDPCP) request for applications (RFA) will be released in the spring of 2022. No RFA was posted in the spring of 2021.
Open Solicitations
• CHART Model – Application deadline of May 11, 2021 for the Community Transformation Track. Additional information can be found on the model webpage or on the Notice of Funding Opportunity page.
• Emergency Triage, Treat, and Transport (ET3) Model – Applications in response to the Notice of Funding Opportunity for medical triage lines, which are due May 11, 2021.
• Primary Care First (PCF) Model – Applications for Cohort 2 PCF model participants are due on May 21, 2021. Applications for additional payers are due on June 18, 2021. See the Request for Applications.
The Quality Calendar
CMS
Call for Measures Pre-Rulemaking/MUC Process: Candidate Quality and Efficiency Measure Submission – May 27
Nominations Impact Assessment of CMS Quality and Efficiency Measures TEP – May 17 MACRA Episode Based Cost Measures- Wave 4 – May 21 TEP for Refinement of LTCH, IRF, SNF/NF, and HH Function Measures – May 28
Webinar
Hospice Quality Reporting Program Forum – May 12
NQF
Comments Social Risk Trial – May 18
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Requests for Nominations
Committee Nomination
Due Date
Centers for Medicare and Medicaid Services (CMS)
Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests Continuous
National Institutes of Health (NIH)
Advisory Commission on Childhood Vaccines Continuous
Council on Graduate Medical Education Continuous
National Advisory Council on the National Health Service Corps Continuous
Advisory Committee on Training in Primary Care Medicine and Dentistry Continuous
National Advisory Council on Nurse Education and Practice Continuous
National Advisory Council on Migrant Health Continuous
Advisory Committee on Organ Transplantation Continuous
Advisory Council on Blood Stem Cell Transplantation Continuous
Department of Health and Human Services (HHS) and Other Agency Nominations
Flow Cytometry Quantitation Consortium Continuous
Nine existing Federal Advisory Committees Continuous
Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment Continuous
National Advisory Council on Migrant Health Continuous
National Advisory Committee on Occupational Safety and Health May 10, 2021
Blood Products Advisory Committee May 25, 2021
Advisory Council on Alzheimer's Research, Care, and Services May 31, 2021
Muscular Dystrophy Coordinating Committee June 7, 2021
Healthcare Infection Control Practices Advisory Committee September 17, 2021
Advisory Committee on Interdisciplinary, Community-Based Linkages September 30, 2021
Advisory Committee on Training in Primary Care Medicine and Dentistry September 30, 2021
Lead Exposure and Prevention Advisory Committee December 15, 2021
Upcoming Federal Regulatory Meetings Meeting Date Location/Other Logistics
Agency for Healthcare Research and Quality (AHRQ)
Health Services Research Initial Review Group Committee
Dates and locations can be found here.
AHRQ's Health Services Research Initial Review Group Subcommittees
Dates and locations can be found here.
Centers for Disease Control and Prevention (CDC)
Lead Exposure and Prevention Advisory Committee May 14, 2021, 9 am – 4:30 pm
Teleconference
Board of Scientific Counselors, National Institute for Occupational Safety and Health
May 19, 2021, 10 am – 4 pm
Web conference
Board of Scientific Counselors, National Center for Health Statistics
May 19, 2021, 11 am – 5:30 pm
Teleconference
Board of Scientific Counselors, Center for Preparedness and Response
May 19, 2021, 12:30 pm – 3:30 pm; May-20, 2021, 12:30 pm – 2:30 pm
Virtual meeting
Healthcare Infection Control Practices Advisory Committee
June 3, 2021, 9 am – 3 pm
Virtual meeting
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Meeting Date Location/Other Logistics
Community Preventive Services Task Force
June 9, 2021, 8:30 am – 6 pm; June 10, 2021, 8:30 am – 5 pm
Web conference
Advisory Council for the Elimination of Tuberculosis June 15, 2021, 10 am – 3:45 pm
Audio and web conference
Subcommittee for Dose Reconstruction Reviews June 16, 2021, 10:30 am – 2:30 pm
Audio conference
Mine Safety and Health Research Advisory Committee June 21, 2021, 10 am – 2:30 pm
Web conference
Advisory Board on Radiation and Worker Health June 23, 2021, 10:30 am – 1 pm
Teleconference
Advisory Committee on Immunization Practices June 23-24, 2021, 9 am – 5:30 pm
Webcast
Centers for Medicare and Medicaid Services (CMS)
Town Hall Meeting on the FY 2021 Applications for New Medical Services and Technologies Add-On Payments
Further details about meeting places and times can be found here.
Public meeting to receive comments and recommendations (including data on which recommendations are based) on the appropriate basis for establishing payment amounts for new or substantially revised Healthcare Common Procedure Coding System codes being considered for Medicare payment under the Clinical Laboratory Fee Schedule (CLFS) for calendar year (CY) 2022
June 24, 2021, 9 am – 5 pm
Virtual
Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests
July 28, 2021 and July 29, 2021
Virtual
Food and Drug Administration (FDA)
Public Advisory Committee Meeting of the Blood Products Advisory Committee
Dates and locations can be found here.
Science Advisory Board to the National Center for Toxicological Research
May 11, 2021, 9 am – 5:50 pm; May 12, 2021, 8 am – 11:30 am
Online teleconferencing platform
Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee
May 11, 2021, 10 am – 3 pm; May 12, 2021, 12 pm – 5 pm
Virtual
Potential Medication Error Risks with Investigational Drug Container Labels
May 18, 2021, 1 pm – 4 pm; May 19, 2021, 10 am – 1 pm
Webcast
FDA Science Forum 2021
May 26, 2021, 9 am – 3:30 pm; May 27, 2021, 9 am – 2 pm
Virtual
Endocrinologic and Metabolic Drugs Advisory Committee
May 27, 2021 Online teleconferencing platform
Morphine Milligram Equivalents: Current Applications and Knowledge Gaps, Research Opportunities, and Future Directions
June 7 and 8, 2021, 9 am – 5 pm
Virtual
Model Informed Drug Development Approaches for Immunogenicity Assessments
June 9, 2021, 8 am – 5 pm
Online teleconferencing platform
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Meeting Date Location/Other Logistics
Pharmacy Compounding Advisory Committee June 9, 2021, 10 am – 5:05 pm
Online teleconferencing platform
FY 2021 Generic Drug Science and Research Initiatives Workshop
June 23, 2021, 8:30 am – 4:30 pm
Virtual
Healthcare Resources and Services Administration (HRSA)
Meeting of the Advisory Committee on Interdisciplinary, Community Based Linkages
Further details about meeting places and times can be found here.
Advisory Committee on Training and Primary Care Medicine and Dentistry (ACTPCMD)
Public meetings for 2020 calendar year
Council on Graduate Medical Education Public meetings for 2021 calendar year
Advisory Committee on Childhood Vaccines Public meetings for the 2021 calendar year
Advisory Committee on Heritable Disorders in Newborns and Children
May 13-14, 2021 Webinar
National Institutes of Health (NIH) All of Us Research Program will host four Tribal Consultations to consult on the best practices for engaging with Tribal Nations to facilitate the inclusion of American Indian and Alaska Native (AI/AN) populations in this program
Further details about meeting places and times can be found here.
The National Advisory Neurological Disorders and Stroke Council
Further details about meeting times can be found here.
National Advisory Mental Health Council Further details about meeting places and times can be found here.
President's Cancer Panel Further details about meeting places and times can be found here.
National Advisory Council on Drug Abuse May 11, 2021 National Institutes of Health, National Institute on Drug Abuse, 301 North Stonestreet Avenue, Bethesda, MD 20892 (Virtual Meeting)
National Advisory Council on Aging May 12, 2021, 8 am – 12:45 pm
NIH Videocasting and Podcasting website
National Diabetes and Digestive and Kidney Diseases Advisory Council
May 12-13, 2021 National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Virtual Meeting)
National Advisory General Medical Sciences Council May 12-13, 2021 Natcher Building, 45 Center Drive, Bethesda, MD 20892 (Virtual Meeting)
National Advisory Council for Complementary and Integrative Health
May 14, 2021 National Institutes of Health, Democracy 2, 6707 Democracy Boulevard, Bethesda, MD 20817, (Virtual Meeting)
Board of Scientific Counselors Chairs Meeting May 14, 2021 National Institutes of Health, 1 Center Drive, Building 1, Room 160, Bethesda, MD 20892 (Zoom Meeting)
National Cancer Institute Board of Scientific Advisors May 15, 2021 Virtual meeting
National Advisory Council for Human Genome Research May 17-18, 2021 National Human Genome Research Institute, National Institutes of Health, 6700B Rockledge Drive, Suite 1100, Bethesda, MD 20892 (Virtual Meeting)
National Advisory Council for Nursing Research May 18, 2021 Videocast
National Arthritis and Musculoskeletal and Skin Diseases Advisory Council
May 18, 2021, 9:30 am – 12:30 pm
National Institute of Arthritis and Musculoskeletal and Skin Diseases, 6701 Democracy Blvd., Democracy I, Suite 800, Bethesda, MD 20892-4872, http://videocast.nih.gov (Virtual Meeting)
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Meeting Date Location/Other Logistics
National Advisory Council for Biomedical Imaging and Bioengineering
May 19, 2021 National Institutes of Health, Democracy II, 6707 Democracy Boulevard, Bethesda, MD 20892 (Virtual Meeting)
Council of Councils May 20, 2021, 11 am – 4:15 pm
Virtual meeting
National Deafness and Other Communication Disorders Advisory Council
May 20-21, 2021 National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Virtual Meeting)
National Advisory Council on Minority Health and Health Disparities
May 25, 2021 National Institutes of Health, 6707 Democracy Boulevard, Bethesda, MD 20892 (Virtual Meeting)
National Advisory Dental and Craniofacial Research Council
May 26, 2021 National Institutes of Health National Institute of Dental and Craniofacial Res. 6701 Democracy Blvd. Bethesda, MD 20892 (Virtual Meeting)
National Advisory Neurological Disorders and Stroke Council
May 26-27, 2021 National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Virtual Meeting)
Interagency Coordinating Committee on the Validation of Alternative Methods
May 27, 2021, 9 am – 3 pm
Webcast
National Advisory Environmental Health Sciences Council
June 1-2, 2021
Division of Extramural Research and Training, National Institute of Environmental Health Sciences, 111 T.W. Alexander Drive, Research Triangle Park, NC 27709 (Virtual Meeting)
Muscular Dystrophy Coordinating Committee June 2, 2021 National Institutes of Health, Neuroscience Center, 6001 Executive Blvd., Bethesda, MD 20892 (Virtual Meeting)
National Advisory Allergy and Infectious Diseases Council
June 7, 2021 National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Virtual Meeting)
AIDS Research Advisory Committee June 7, 2021 National Institutes of Health, 5601 Fishers Lane, Room LD30, Bethesda, MD 20892 (Virtual Meeting)
National Advisory Eye Council June 11, 2021 Virtual meeting
Office of AIDS Research Advisory Council June 24, 2021 NIH Videocast
National Advisory General Medical Sciences Council September 1-2, 2021
National Institutes of Health, Natcher Building, 45 Center Drive, Bethesda, MD 20892 (Virtual Meeting)
National Diabetes and Digestive and Kidney Diseases Advisory Council
September 1-2, 2021
National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Virtual Meeting)
National Advisory Council on Aging September 15, 2021, 8 am – 1 pm
NIH Videocasting and Podcasting website
Substance Abuse and Mental Health Services Administration (SAMHSA)
Subcommittee meetings of the Interdepartmental Serious Mental Illness Coordinating Committee
Further details about meeting times can be found here.
Veterans Administration (VA)
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Meeting Date Location/Other Logistics
Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit Review Board (JBL/CS SMRB)
Further details about meeting times can be found here.
Rehabilitation Research and Development Service Scientific Merit Review Board
Further details about meeting places and times can be found here.
Subcommittees of the Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit Review Board
Further details about meeting places and times can be found here.
National Research Advisory Council June 2, 2021, 11 am – 2 pm
Virtual meeting
Department of Health and Human Services (HHS) and Other Agency Meetings
Human Studies Review Board (of the Environmental Protection Agency (EPA))
Further details about meeting places and times can be found here.
National Advisory Council on Nurse Education and Practice
Further details about meeting places and times can be found here.
2021 meetings of the Physician-Focused Payment Model Technical Advisory Committee
Further details about meeting places and times can be found here.
Council of Councils Further details about meeting places and times can be found here.
National Advisory Committee on the National Health Service Corps
Further details about meeting places and times can be found here.
Advisory Commission on Childhood Vaccines Further details about meeting places and times can be found here.
National Advisory Council on Migrant Health Further details about meeting places and times can be found here.
Healthcare Common Procedure Coding System (HCPCS) public meetings
Further details about meeting places and times can be found here.
Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests
Further details about meeting places and times can be found here.
Health Information Technology Advisory Committee Further details about meeting places and times can be found here.
Advisory Committee on Training in Primary Care Medicine and Dentistry
Further details about meeting places and times can be found here.
Informal Stakeholder Listening Session on 74th World Health Assembly
May 13, 2021, 10 am – 12 pm
Virtual
State All Payer Claims Databases Advisory Committee May 19, 2021, 9 am – 5:30 pm
Virtual
National Clinical Care Commission May 19, 2021 and June 1, 2021
Virtual
National Advisory Council on Migrant Health May 25, 2021, 1 pm – 5 pm
Webinar
National Biodefense Science Board May 26, 2021 Teleconference
Advisory Committee on the Medical Uses of Isotopes May 27, 2021, 1 pm – 5 pm
Teleconference
Air Ambulance and Patient Billing (AAPB) Advisory Committee
May 27-28, 2021, 10 am – 5:30 pm
Virtual meeting
COVID-19 Health Equity Task Force May 28, 2021 Virtual meeting
National Toxicology Program (NTP) Board of Scientific Counselors (BSC)
June 8, 2021, 12:30 pm – 5 pm
Virtual meeting
National Vaccine Advisory Committee June 16-17, 2021 Virtual meeting
Opportunities for Public Comment & Federal Agency Notices
Federal Rules, Regulations and Notices Effective
Date Comments
Due
Centers for Disease Control and Prevention (CDC)
Evaluation of Venous Thromboembolism Prevention Practices in U.S. Hospitals May 11, 2021
Behavioral Risk Factor Surveillance System May 11, 2021
Assisted Reproductive Technology (ART) Program Reporting System May 11, 2021 Medical Monitoring Project May 11, 2021
Development of CDC's Let's Stop HIV Together Social Marketing Campaign for Consumers May 11, 2021
8 Highlighting indicates an item is new in this edition of the Regulatory Review Hart Health Strategies Inc. www.hhs.com
Federal Rules, Regulations and Notices Effective
Date Comments
Due
Business Proposal Forms for Quality Improvement Organizations (QIOs); Medicare/Medicaid Psychiatric Hospital Survey Data and Supporting Regulations; Community Mental Health Center Cost Report; and Request for Termination of Premium-Hospital and or Supplementary Medical Insurance
May 13, 2021
Assessment and Monitoring of Breastfeeding-Related Maternity Care Practices in Intrapartum Care Facilities in the United States and Territories
May 18, 2021
The EDN Tuberculosis Follow-Up Worksheet for Newly-Arrived Persons with Overseas Tuberculosis Classifications
May 18, 2021
Lighting Interventions for Improving the Health, Safety, and Well-Being of Underground Mineworkers
May 18, 2021
National Program of Cancer Registries Program Evaluation Instrument May 25, 2021
Hospice Request for Certification and Supporting Regulations and Laboratory Personnel Report (CLIA) and Supporting Regulations
June 1, 2021
Environmental Health Specialists Network (EHS-Net) Program June 4, 2021
Harm Reduction Toolkit for Non-Prescription Syringe Sales in Community Pharmacies June 4, 2021
Proposed rule that would update the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities
June 7, 2021
Draft Recommendations for Prevention and Control of Infections in Neonatal Intensive Care Unit Patients: Central Line-associated Blood Stream Infections
June 8, 2021
Temporary Halt in Residential Evictions to Prevent the Further Spread of COVID-19 June 11, 2021
CLIA Collection of Information Requirements Related to SARS-CoV-2 Test Results Reporting June 14, 2021
American Academy of Pediatrics (AAP) Neurodevelopmental Extension for Community Health Outcomes (ECHO)program on Children with Fetal Alcohol Spectrum Disorders (FASD)
June 15, 2021
Integrated Viral Hepatitis Surveillance and Prevention Funding for Health Departments June 15, 2021
SimpleReport Mobile Application June 15, 2021
Chronic Disease Self-Management Questionnaire June 15, 2021
Drug Overdose Surveillance and Epidemiology June 25, 2021
National Learning Community for HIV CBO Leadership Evaluation June 25, 2021
Phased Approach to the Resumption of Passenger Operations June 29, 2021
World Trade Center Health Program Enrollment, Petitions, Designated Representative/HIPAA Authorization, and Member Satisfaction
June 29, 2021
Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery July 6, 2021
A Baseline of Injury and Psychosocial Stress for Applied Behavior Analysis Workers July 6, 2021
Changes in assisted reproductive technology (ART) data validation selection process Oct. 1, 2021
Centers for Medicare and Medicaid Services (CMS)
Quarterly notice listing CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January through March 2021
March 31, 2021
Disclosures Required of Certain Hospitals and Critical Access Hospitals Regarding Physician Ownership and Evaluation of the Centers for Medicare & Medicaid Services (CMS) Network of Quality Improvement and Innovation Contractors (NQIIC)
May 10, 2021
Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of 'Reasonable and Necessary
May 15, 2021
Medicaid Eligibility and Enrollment (EE) Implementation Advanced Planning Document (IAPD) Template
May 17, 2021
Generic Clearance for Evaluation of Stakeholder Training—Health Insurance Marketplace and Market Stabilization Programs
May 24, 2021
Application for Participation in the Intravenous Immune Globulin (IVIG) Demonstration May 24, 2021
The State Flexibility to Stabilize the Market Grant Program May 25, 2021
Receipt of an application from the American Diabetes Association (ADA) for continued recognition as a national accrediting organization (AO) for accrediting entities that wish to furnish diabetes outpatient self-management training services to Medicare beneficiaries
May 27, 2021
Receipt of an application from the Association of Diabetes Care and Education Specialists for continued recognition as a national accrediting organization (AO) for accrediting entities that wish to furnish diabetes outpatient self-management training services to Medicare beneficiaries
May 27, 2021
Electronic Submission of Medicare Graduate Medical Education (GME) Affiliation Agreements; and Collection of Encounter Data from MA Organizations
May 28, 2021
9 Highlighting indicates an item is new in this edition of the Regulatory Review Hart Health Strategies Inc. www.hhs.com
Federal Rules, Regulations and Notices Effective
Date Comments
Due
National Implementation of Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS); and Hospice Facility Cost Report Form
June 1, 2021
Proposed rule that would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2022
June 7, 2021
Rule proposing updates to the hospice wage index, payment rates, and aggregate cap amount for Fiscal Year 2022
June 7, 2021
Proposed rule that would update the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2022
June 7, 2021
Medicare Health Outcomes Survey; and Evaluating Coverage to Care in Communities June 7, 2021
Medicare Advantage Chronic Care Improvement Program (CCIP) Attestations; Medicare Beneficiary Experiences with Care Survey (MBECS) System; Program Integrity II; Medicare Registration Application; and Organ Procurement Organization/Histocompatibility Laboratory Cost Report
June 8, 2021
Decision to approve The Joint Commission for continued recognition as a national accrediting organization for hospices
June 18, 2021
National Implementation of the Outpatient and Ambulatory Surgery Consumer Assessment of Healthcare Providers and Systems (OAS CAHPS) Survey
June 22, 2021
Request for Certification as Supplier of Portable X-Ray Services under the Medicare/Medicaid Program
June 28, 2021
Final rule extending the length of the Comprehensive Care for Joint Replacement (CJR) model through December 31, 2024
July 2, 2021
Consumer Assessment of Healthcare Providers and Systems (CAHPS) Survey for Merit-based Incentive Payment Systems (MIPS); and Administrative Requirements for Section 6071 of the Deficit Reduction Act
July 2, 2021
Identifying Medicaid Payment for Physician Administered Drugs July 6, 2021
Final rule setting forth payment parameters and provisions related to the risk adjustment program and cost-sharing parameters
July 6, 2021
Section 1115 Demonstration Projects Regulations July 6, 2021
Extension of the timeline for publication of a Medicare final rule Modernizing and Clarifying the Physician Self-Referral Regulations
Aug. 31, 2021
Final rule revising regulations for the Medicare Advantage (Part C) program, Medicare Prescription Drug Benefit (Part D) program, Medicaid program, Medicare Cost Plan program, and Programs of All-Inclusive Care for the Elderly (PACE)
Jan. 1, 2022
Food and Drug Administration (FDA)
Withdrawal of the notice published in the Federal Register of January 15, 2021, announcing a Statement of Policy indicating that FDA will publish certain information regarding the timeline for its review of drug product applications
May 3, 2021
FDA Recall Regulations May 10, 2021 Solicitation of comments on information collection associated with prescription drug marketing under the Prescription Drug Marketing Act of 1987 and the Prescription Drug Amendments of 1992
May 11, 2021
Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice
May 13, 2021
Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring May 14, 2021 Solicitation of comments on the information collection provisions associated with export certificate applications for FDA-regulated human food and cosmetic products
May 17, 2021
Solicitation of comments on the information collection requirements relating to the regulations that state that protocols for samples of biological products must be submitted to the Agency
May 17, 2021
List of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need May 24, 2021
Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim
May 24, 2021
Medical Device Recall Authority June 4, 2021
513(g) Request for Information June 7, 2021
Potential Approach for Defining Durations of Use for Medically Important Antimicrobial Drugs Intended for Use In or On Feed: A Concept Paper
June 11, 2021
10 Highlighting indicates an item is new in this edition of the Regulatory Review Hart Health Strategies Inc. www.hhs.com
Federal Rules, Regulations and Notices Effective
Date Comments
Due
The Drug Supply Chain Security Act Pilot Project Program and Enhanced Drug Distribution Security; Public Meeting; Request for Comments
June 22, 2021
Request for comments regarding issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, and identifying system attributes that are necessary to implement the requirements established under the Drug Supply Chain Security Act
June 28, 2022
Solicitation of comments on electronic user fee payment request forms June 28, 2022
Solicitation of comments on the collection of information associated with the establishment and operation of clinical trial data monitoring committees
June 28, 2022
Solicitation of comments on information collection associated with Agency guidance documents pertaining to pharmacies, outsourcing facilities, and other entities with regard to human drug compounding, repackaging, and related activities
June 28, 2022
Solicitation of comments on the information collection associated with requirements for medical device reporting for user facilities, manufacturers, importers, and distributors of medical devices
June 28, 2022
Solicitation of comments on information collection associated with prescription drug advertising June 28, 2022
Healthcare Resources and Services Administration (HRSA) The Maternal, Infant, and Early Childhood Home Visiting Program Performance Measurement Information System
May 19, 2021
National Survey of Organ Donation Attitudes and Practices June 18, 2021
Updates to Uniform Standard for Waiver of the Ryan White HIV/AIDS Program Core Medical Services Expenditure Requirement
June 21, 2021
Health Center Program: COVID-19 Data Collection Tools June 22, 2021
Modification of the definition it uses of rural for the determination of geographic areas eligible to apply for or receive services funded by FORHP's rural health grants
Oct. 1, 2021
Date that FDA will no longer support electronic submissions using the Electronic Common Technical Document (eCTD) Backbone Files Specification for Module 1 Version 1.3, Comprehensive Table of Contents Headings and Hierarchy Version 1.2.2, U.S. Regional Document Type Definition (DTD) Version 2.01, and U.S. Regional Stylesheet Version 1.1, and will require electronic submissions to be submitted using eCTD Module 1 U.S. Regional DTD Version 3.3
March 1, 2022
National Institutes of Health (NIH)
The Impact of Clinical Research Training and Medical Education at the Clinical Center on Physician Careers in Academia and Clinical Research
April 26, 2021
Public Health Service (PHS) Applications and Pre-Award Reporting Requirements June 12, 2021
Public Health Service (PHS) Post-award Reporting Requirements Including Research Performance Progress Report (RPPR) Collection
June 12, 2021
Inclusion Enrollment Report Form Conversion to Common Form June 21, 2021
Generic Clearance to Collect Stakeholder Feedback on the Research Domain Criteria (RDoC) Initiative
July 4, 2021
NIH Policy for Data Management and Sharing Jan. 25, 2023
Department of Health and Human Services (HHS) and Other Agency Comment Opportunities and Notices
Notice listing all currently HHS-certified laboratories and IITFs May 3, 2021
Placement of four specified fentanyl-related substances permanently in schedule I of the Controlled Substances Act
May 4, 2021
Solicitation of comments on a revision to the information collection requirements related to the National Ombudsman Reporting System and Older Americans Act Title VII
May 10, 2021
ASPA COVID-19 Public Education Campaign Market Research May 10, 2021
Access, Exchange and Use of Social Determinants of Health Data in Clinical Notes May 10, 2021
The Protection of Human Subjects: Assurance Identification/IRB Certification/Declaration of Exemption Form
May 14, 2021
National Animal Health Monitoring System's On-Farm Monitoring of Antimicrobial Use and Resistance in U.S. Broiler Production Study
May 17, 2021
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Federal Rules, Regulations and Notices Effective
Date Comments
Due
Standards for compliance by family planning services projects authorized by Title X of the Public Health Service Act
May 17, 2021
Seven types of reserved class I devices that the Department had determined no longer require premarket notification
May 17, 2021
User Fees for the Administration of the Toxic Substances Control Act (TSCA) May 18, 2021
VA proposal to amend its medical regulations to implement legislation providing it stand-alone authority to provide surgical procedures to remove a solid organ or bone marrow from a live donor for transplantation into a veteran and to furnish the live donor any care or services before and after the surgical procedure required in connection with the veteran's transplantation procedure
May 24, 2021
National Blood Collection & Utilization Survey May 24, 2021
Claim for Medical Reimbursement Form May 24, 2021
Recordkeeping and Reporting Requirements for Allegations of Significant Adverse Reactions to Human Health or the Environment
May 28, 2021
Seventy-Fourth Report of the ITC to the Administrator of the Environmental Protection Agency May 28, 2021
Evaluating the Association between Serum Concentrations of Per- and Polyfluoroalkyl Substances (PFAS) and Symptoms and Diagnoses of Selected Acute Viral Illnesses
June 4, 2021
National Survey on Drug Use and Health June 4, 2021
Survey of Healthcare Experiences of Patients June 7, 2021
VA adoption as final, with changes, a proposed rule amending its medical regulations to establish standards for VA clinical laboratories
June 7, 2021
Components Study of REAL Essential Curriculum June 8, 2021
National strategy on vector-borne diseases June 11, 2021
Protection of Human Subjects: Assurance of Compliance with Federal Policy/IRB Review/IRB Recordkeeping/Informed Consent/Consent Documentation
June 14, 2021
Bloodborne Pathogens Standard June 14, 2021
Safety and Health Information Collection June 18, 2021
Proposal to simplify the process for RWHAP Part A, B, and C recipients to request a waiver of the core medical services expenditure amount requirement by replacing HRSA Policy Number 13-07, “Uniform Standard for Waiver of Core Medical Services Requirement for Grantees Under Parts, A, B, and C”
June 21, 2021
Exempt chemical preparations received by the Drug Enforcement Administration June 22, 2021
The AHRQ Safety Program for Methicillin-Resistant Staphylococcus aureus (MRSA) Prevention July 2, 2021
Medical Office Survey on Patient Safety Culture Database July 2, 2021
Final rule implementing a further delay until July 20, 2021, of the effective date of the rule entitled “Implementation of Executive Order on Access to Affordable Life- saving Medications”
July 20, 2021
Federal Medical Assistance Percentages (FMAP), Enhanced Federal Medical Assistance Percentages (eFMAP), and disaster-recovery FMAP adjustments for Fiscal Year 2022
Oct. 1, 2021
Tobacco Products; Required Warnings for Cigarette Packages and Advertisements Jan. 14, 2022
Securing Updated and Necessary Statutory Evaluations Timely March 22, 2022
Notice of the delay of the effective date of certain amendments to the safe harbors to the Federal anti-kickback statute that were promulgated in a final rule
Jan. 1, 2023
FDA Guidance Documents
Guidance Title Stage Comments
Due
Additional draft and revised draft product-specific guidances Draft May 24, 2021
Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products; Draft Guidance for Industry; Availability
Draft June 14, 2021
Nonclinical Testing of Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases
Draft June 28, 2021
Draft recommendations for new permitted daily exposures (PDEs) for the residual solvents 2-methyltetrahydrofuran, cyclopentyl methyl ether, and tert-butyl alcohol
Draft July 26, 2024
FDA guidance documents related to the Coronavirus Disease 2019 (COVID-19) public health emergency
Final Anytime
12 Highlighting indicates an item is new in this edition of the Regulatory Review Hart Health Strategies Inc. www.hhs.com
Pending OMB Review
Title Stage Received by OMB
Release Timetable
Centers for Medicare and Medicaid Services (CMS)
Premarket Tobacco Product Applications and Recordkeeping Requirements
Final Rule Apr. 5, 2021 Jan. 2021
Format and Content of Reports Intended to Demonstrate Substantial Equivalence
Final Rule Apr. 5, 2021 Jan. 2021
Recommendations for Sponsors of All Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products
Notice Apr. 14, 2021 N/A
CY 2022 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B
Proposed Rule
Apr. 21, 2021 Jun. 2021
CY 2022 Home Health Prospective Payment System Rate Update, Home Infusion Therapy Services, and Quality Reporting Requirements
Proposed Rule
Apr. 30, 2021 Jun. 2021
CY 2022 Changes to the End-Stage Regnal Disease (ESRD) Prospective Payment System and Quality Incentive Program
Proposed Rule
May 3, 2021 Jun. 2021
Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary”
Final Rule May 5, 2021 N/A
