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603. Considerations for the use of real-world data and real-world evidence to support regulatory decision-making for drug and biological products: guidance for industry

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, August 2023
Subject(s):
Biological Products
Clinical Trials as Topic
Data Analysis
Decision Making
Drug Approval
Drug Industry
Drug and Narcotic Control
Government Regulation
United States
United States.

604. Wholesale distributor verification requirement for saleable returned drug product and dispenser verification requirements when investigating a suspect or illegitimate product: compliance policies : guidance for industry

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, August 2023
Subject(s):
Counterfeit Drugs
Drug Industry
Drug and Narcotic Control
Fraud
Government Regulation
Substandard Drugs
United States
United States.

605. Voluntary consensus standards recognition program for regenerative medicine therapies: guidance for industry

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, October 2023
Subject(s):
Drug Industry
Government Regulation
Reference Standards
Regenerative Medicine -- legislation & jurisprudence
Regenerative Medicine -- standards
Voluntary Programs
United States
Center for Biologics Evaluation and Research (U.S.)

609. Compliance policy regarding blood and blood component donation suitability, donor eligibility and source plasma quarantine hold requirements: guidance for industry

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, October 2023
Subject(s):
Blood Banking -- standards
Blood Donation -- standards
Blood Donors
Donor Selection -- standards
Government Regulation
Guideline Adherence
Plasma
United States

611. Human prescription drug and biological products: labeling for dosing based on weight or body surface area for ready-to-use containers : “dose banding” : guidance for industry

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, October 2023
Subject(s):
Biological Products -- administration & dosage
Drug Dosage Calculations
Drug Industry
Drug Labeling
Drug Packaging
Government Regulation
Injections -- standards
Prescription Drugs -- administration & dosage
Product Labeling
Product Packaging
United States

619. Medicare Part D: CMS should monitor effects of rebates on plan formularies and beneficiary spending : report to congressional requesters

Publication:
Washington, DC : United States Government Accountability Office, September 2023
Subject(s):
Drug Costs
Government Regulation
Legislation, Medical
Medicare Part D -- economics
Medicare Part D -- organization & administration
Prescription Fees
United States
Centers for Medicare & Medicaid Services (U.S.)

620. CARES Act: experts identified safeguards to help selected HHS agencies protect against potential political interference : report to congressional requesters

Publication:
Washington, DC : United States Government Accountability Office, September 2023
Subject(s):
Government Regulation
Legislation, Medical
Politics
Professional Misconduct
United States
United States.
United States. Department of Health and Human Services

621. Medicare Part D: CMS should monitor effects of rebates on drug coverage and spending : testimony before the Subcommittee on Health, Committee on Energy and Commerce, House of Representatives

Publication:
Washington, DC : United States Government Accountability Office, September 19, 2023
Subject(s):
Government Regulation
Legislation, Medical
Medicare Part D -- economics
Medicare Part D -- organization & administration
Prescription Drugs -- economics
United States

622. COVID-19 Provider Relief Fund: HRSA continues to recover remaining payments due from providers : report to congressional committees

Publication:
Washington, DC : United States Government Accountability Office, September 2023
Subject(s):
COVID-19
Disaster Planning -- economics
Disaster Planning -- organization & administration
Fraud -- prevention & control
Government Regulation
Health Personnel -- economics
Legislation, Medical
United States
United States. Health Resources and Services Administration

623. Medicaid program integrity: Opportunities exist for CMS to strengthen use of state auditor findings and collaboration : report to congressional requesters

Publication:
Washington, DC : United States Government Accountability Office, September 2023
Subject(s):
Financial Audit -- legislation & jurisprudence
Financial Audit -- trends
Government Programs
Government Regulation
Legislation, Medical
Medicaid
State Health Planning and Development Agencies
United States
Centers for Medicare & Medicaid Services (U.S.)

624. Nursing homes: Limitations of using CMS data to identify private equity and other ownership : report to the Ranking Member, Committee on Ways and Means, House of Representatives

Publication:
Washington, DC : United States Government Accountability Office, September 2023
Subject(s):
Data Accuracy
Government Regulation
Legislation, Medical
Nursing Homes -- economics
Nursing Homes -- legislation & jurisprudence
Nursing Homes -- organization & administration
United States
Centers for Medicare & Medicaid Services (U.S.)

625. COVID-19: USAID plans to share lessons learned from efforts to meet global vaccination goal : report to congressional addressees

Publication:
Washington, DC : United States Government Accountability Office, September 2023
Subject(s):
COVID-19 Vaccines -- supply & distribution
Global Health
Government Regulation
Immunization Programs
International Cooperation
Legislation, Medical
United States
United States. Agency for International Development

628. Medicare: Performance-based and geographic adjustments to physician payments : testimony before the Subcommittee on Health, Committee on Energy and Commerce, House of Representatives

Publication:
Washington, DC : United States Government Accountability Office, October 19, 2023
Subject(s):
Access to Primary Care -- statistics & numerical data
Government Regulation
Health Inequities
Health Promotion -- economics
Medicare
Primary Prevention
United States

629. Native Hawaiian health care systems program: services, funding, and oversight : report to congressional committees

Publication:
Washington, DC : United States Government Accountability Office, October 2023
Subject(s):
Access to Primary Care
Government Regulation
Health Inequities
Health Promotion
Legislation, Medical
Native Hawaiian or Other Pacific Islander -- statistics & numerical data
Primary Prevention
Hawaii
United States. Health Resources and Services Administration

630. Mental health services: State should collect ongoing feedback to ensure overseas employees’ needs are being met : report to congressional requesters

Publication:
Washington, DC : United States Government Accountability Office, October 2023
Subject(s):
Foreign Professional Personnel -- psychology
Government Employees -- psychology
Government Regulation
Legislation, Medical
Mental Health Services
Workload
United States
United States. Agency for International Development

632. Indian Health Service: Many federal facilities are in fair or poor condition and better data are needed on medical equipment : report to congressional requesters

Publication:
Washington, DC : United States Government Accountability Office, November 2023
Subject(s):
Equipment and Supplies
Facility Regulation and Control
Government Regulation
Health Facility Administration
Health Facility Environment
Legislation, Medical
United States
United States. Indian Health Service

633. Veterans health care: VA has taken steps to improve its appointment scheduling process, but additional actions are needed : testimony before the Special Committee on Aging, U.S. Senate

Publication:
Washington, DC : United States Government Accountability Office, May 17, 2023
Subject(s):
Appointments and Schedules
Government Regulation
Legislation, Medical
Veterans Health Services -- organization & administration
United States
United States. Department of Veterans Affairs

634. FDA could take stronger enforcement action against tobacco retailers with histories of sales to youth and other violations

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2023
Subject(s):
Government Regulation
Health Policy
Tobacco Control
Tobacco Industry -- legislation & jurisprudence
United States
United States. Food and Drug Administration

635. Four states reviewed received increased Medicaid COVID-19 funding even though they terminated some enrollees’ coverage for unallowable or potentially unallowable reasons

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2023
Subject(s):
COVID-19
Financing, Government -- legislation & jurisprudence
Government Regulation
Medicaid -- economics
Florida
Minnesota
New York
Texas

636. CDC provided oversight and assistance: however, ELC recipients still faced challenges in implementing COVID-19 screening testing programs

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2023
Subject(s):
COVID-19 Testing -- instrumentation
Government Programs
Government Regulation
United States
Centers for Disease Control and Prevention (U.S.)

638. Many Medicaid enrollees with opioid use disorder were treated with medication: however, disparities present concerns

Publication:
Washington, D.C. : U.S. Department of Health and Human Services, Office of Inspector General, September 2023
Subject(s):
Ethnic and Racial Minorities -- statistics & numerical data
Government Regulation
Health Inequities
Healthcare Disparities
Medicaid
Morphinans -- supply & distribution
Opiate Substitution Treatment
Opioid-Related Disorders -- drug therapy
United States

639. New Jersey could better ensure that nursing homes comply with federal requirements for life safety, emergency preparedness, and infection control

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2023
Subject(s):
Disaster Planning -- standards
Government Regulation
Guideline Adherence
Infection Control -- standards
Nursing Homes -- legislation & jurisprudence
Nursing Homes -- standards
Safety Management -- standards
New Jersey

640. Medicare could save millions if it implements an expanded hospital transfer payment policy for early discharges to post acute care

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, October 2023
Subject(s):
Financial Audit
Government Regulation
Medicare Part A -- economics
Medicare Part A -- organization & administration
Patient Transfer -- economics
Subacute Care -- economics
United States

642. South Dakota MMIS and E&E system security controls were partially effective and improvements are needed

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, October 2023
Subject(s):
Computer Security -- legislation & jurisprudence
Financial Audit
Government Regulation
Health Information Systems -- legislation & jurisprudence
Medicaid -- organization & administration
South Dakota

643. States face ongoing challenges in meeting third-party liability requirements for ensuring that Medicaid functions as the payer of last resort

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, October 2023
Subject(s):
Financial Audit
Government Regulation
Insurance, Health, Reimbursement -- legislation & jurisprudence
Medicaid -- economics
State Health Plans
United States

646. The risk of misuse and diversion of buprenorphine for opioid use disorder in Medicare Part D continues to appear low: 2022

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, November 2023
Subject(s):
Buprenorphine
Drug Users -- statistics & numerical data
Government Regulation
Medicare Part D -- economics
Opiate Substitution Treatment
Opioid-Related Disorders -- drug therapy
Prescription Drug Diversion -- statistics & numerical data
United States

647. CMS can do more to leverage Medicare claims data to identify unreported incidents of potential abuse or neglect

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, November 2023
Subject(s):
Child Abuse -- legislation & jurisprudence
Elder Abuse -- legislation & jurisprudence
Government Regulation
Medicare -- statistics & numerical data
Vulnerable Populations -- legislation & jurisprudence
United States
Centers for Medicare & Medicaid Services (U.S.)

648. The Food and Drug Administration needs to improve the premarket tobacco application review process for electronic nicotine delivery systems to protect public health

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, November 2023
Subject(s):
Electronic Nicotine Delivery Systems -- supply & distribution
Government Regulation
Tobacco Control -- legislation & jurisprudence
United States
United States. Food and Drug Administration

649. Pennsylvania implemented our prior audit recommendations for critical incidents involving Medicaid enrollees with developmental disabilities but should continue to take action to reduce unreported incidents

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, November 2023
Subject(s):
Developmental Disabilities
Government Regulation
Mandatory Reporting
Nursing Homes -- legislation & jurisprudence
Nursing Homes -- standards
Safety Management -- standards
Pennsylvania

650. Louisiana should improve its oversight of nursing homes’ compliance with requirements that prohibit employment of individuals with disqualifying background checks

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, November 2023
Subject(s):
Criminal Behavior
Government Regulation
Nursing Homes -- legislation & jurisprudence
Nursing Homes -- standards
Workplace -- standards
Louisiana

651. Connecticut implemented our prior audit recommendations and generally complied with federal and state requirements for reporting and monitoring critical incidents

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, December 2023
Subject(s):
Government Regulation
Group Homes -- standards
Guideline Adherence -- legislation & jurisprudence
Mandatory Reporting
Medical Errors -- legislation & jurisprudence
Connecticut

652. Washington state did not ensure that selected nursing homes complied with federal requirements for life safety, emergency preparedness, and infection control

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, December 2023
Subject(s):
Disaster Planning -- standards
Financial Audit
Infection Control -- standards
Nursing Homes -- legislation & jurisprudence
Nursing Homes -- standards
Safety Management -- standards
Government Regulation
Washington
Centers for Medicare & Medicaid Services (U.S.)

656. Healthy eating Rx: improving nutrition through health care

Author(s):
Glickman, Dan, author
Frist, William H., author
Shalala, Donna E., author
Veneman, Ann Margaret, 1949- author
Publication:
Washington, DC : Bipartisan Policy Center, November 2023
Subject(s):
Diet, Healthy
Food Assistance
Government Regulation
Health Policy
Nutrition Policy
Nutrition Therapy
United States
Supplemental Nutrition Assistance Program (U.S.)

657. Medicare cognitive assessments: utilization tripled between 2018 and 2022, but challenges remain : report to congressional committees

Publication:
Washington, DC : United States Government Accountability Office, December 2023
Subject(s):
Alzheimer Disease
Government Regulation
Healthcare Disparities
Medicare
Mental Status and Dementia Tests -- statistics & numerical data
Neurocognitive Disorders
United States
United States.
Centers for Medicare & Medicaid Services (U.S.)

658. Private health insurance: Roll out of independent dispute resolution process for out-of-network claims has been challenging : report to congressional committees

Publication:
Washington, DC : United States Government Accountability Office, December 2023
Subject(s):
Dissent and Disputes
Government Regulation
Health Benefit Plans, Employee
Health Expenditures
Insurance Claim Review
Insurance, Health, Reimbursement
Negotiating
United States

661. Defense health care: DOD assessment needed to ensure TRICARE behavioral health coverage goals are being met : report to congressional committees

Publication:
Washington, DC : United States Government Accountability Office, December 2023
Subject(s):
Behavioral Medicine
Government Programs
Government Regulation
Legislation, Medical
Mental Health Services
Military Family
Military Health Services
United States
United States. Department of Defense

664. Direct-to-consumer prescription drug advertisements: presentation of the major statement in a clear, conspicuous, and neutral manner in advertisements in television and radio format final rule : questions and answers : guidance for industry

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, December 2023
Subject(s):
Direct-to-Consumer Advertising -- legislation & jurisprudence
Drug Industry
Government Regulation
Legislation, Drug
Prescription Drugs
United States

671. Review of personnel shortages in federal health care programs during the COVID-19 pandemic

Publication:
Washington, D.C. : Pandemic Response Accountability Committee, September 2023
Subject(s):
COVID-19 -- economics
Government Programs
Government Regulation
Health Workforce -- statistics & numerical data
United States
United States. Department of Defense
United States. Department of Health and Human Services
United States. Department of Justice
United States. Department of Veterans Affairs

672. Georgia could better ensure that nursing homes comply with federal requirements for life safety, emergency preparedness, and infection control

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2023
Subject(s):
Disaster Planning -- standards
Government Regulation
Infection Control -- standards
Nursing Homes -- legislation & jurisprudence
Nursing Homes -- standards
Safety Management -- standards
Georgia

673. CDC’S Vaccines for Children program recipients did not conduct site visits at some providers as required

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2023
Subject(s):
Child Health
Government Programs
Government Regulation
Immunization Programs
Vaccines -- supply & distribution
United States
Centers for Disease Control and Prevention (U.S.)
Vaccines for Children (Program)

674. Key strategies that states used for managing Medicaid and marketplace enrollment during the COVID-19 PHE

Publication:
Washington, D.C. : U.S. Department of Health and Human Services, Office of Inspector General, September 2023
Subject(s):
COVID-19
Eligibility Determination -- organization & administration
Government Regulation
Health Insurance Exchanges
Medicaid -- organization & administration
State Health Planning and Development Agencies
United States

675. New York did not ensure that a managed care organization complied with requirements for denying prior authorization requests

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2023
Subject(s):
Government Regulation
Managed Care Programs -- legislation & jurisprudence
Medicaid -- legislation & jurisprudence
Medicaid -- organization & administration
Prior Authorization -- economics
New York

676. The Provider Relief Fund helped select nursing homes maintain services during the COVID-19 pandemic, but some found guidance difficult to use

Publication:
Washington, D.C. : U.S. Department of Health and Human Services, Office of Inspector General, December 2023
Subject(s):
Costs and Cost Analysis
COVID-19 -- economics
Government Programs
Government Regulation
Nursing Homes -- economics
Nursing Homes -- organization & administration
United States
United States. Department of Health and Human Services

677. The consistently low percentage of Medicare enrollees receiving medication to treat their opioid use disorder remains a concern

Publication:
Washington, D.C. : U.S. Department of Health and Human Services, Office of Inspector General, December 2023
Subject(s):
Government Regulation
Medicare
Opiate Overdose -- prevention & control
Opiate Substitution Treatment
Opioid-Related Disorders -- drug therapy
United States

679. The future of remote patient monitoring

Author(s):
Harris, Julia, (Of Bipartisan Policy Center), author
Curtis, Mikayla, author
Sandalow, Maya, author
Hoagland, G. William, author
Serafini, Marilyn, author
Publication:
Washington, DC : Bipartisan Policy Center, January 2024
Subject(s):
Computer Security
Electronic Health Records
Government Regulation
Health Equity
Health Policy
Insurance, Health, Reimbursement
Medicaid
Medical Device Legislation
Medicare
Remote Sensing Technology
Telemedicine
United States

680. Healthcare workforce

Author(s):
White, Robert, (Of Oklahoma Bar), author
Publication:
[Toronto, Ontario] : Thomson Reuters, 18-December-2023
Subject(s):
Dentists -- legislation & jurisprudence
Government Regulation
Health Workforce -- legislation & jurisprudence
Licensure -- legislation & jurisprudence
Nurses -- legislation & jurisprudence
Pharmacists -- legislation & jurisprudence
Physicians -- legislation & jurisprudence
State Government
United States

681. Hospital mergers and public accountability: Tennessee and Virginia employ a certificate of public advantage

Author(s):
Brown, Erin C. Fuse, author
Publication:
New York, NY : Milbank Memorial Fund, September 2018
Subject(s):
Antitrust Laws
Health Facility Merger -- organization & administration
Social Responsibility
Government Regulation
Health Policy
Health Services Accessibility
Medicaid
Public Opinion
Quality of Health Care
State Government
Humans
Tennessee
United States
Virginia
United States. Federal Trade Commission.

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